Search results for: stability indicating RP-HPLC method validation
Commenced in January 2007
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Edition: International
Paper Count: 22420

Search results for: stability indicating RP-HPLC method validation

22420 Analytical Method Development and Validation of Stability Indicating Rp - Hplc Method for Detrmination of Atorvastatin and Methylcobalamine

Authors: Alkaben Patel

Abstract:

The proposed RP-HPLC method is easy, rapid, economical, precise and accurate stability indicating RP-HPLC method for simultaneous estimation of Astorvastatin and Methylcobalamine in their combined dosage form has been developed.The separation was achieved by LC-20 AT C18(250mm*4.6mm*2.6mm)Colum and water (pH 3.5): methanol 70:30 as mobile phase, at a flow rate of 1ml/min. wavelength of this dosage form is 215nm.The drug is related to stress condition of hydrolysis, oxidation, photolysis and thermal degradation.

Keywords: RP- HPLC, atorvastatin, methylcobalamine, method, development, validation

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22419 Forced Degradation Study of Rifaximin Formulated Tablets to Determine Stability Indicating Nature of High-Performance Liquid Chromatography Analytical Method

Authors: Abid Fida Masih

Abstract:

Forced degradation study of Rifaximin was conducted to determine the stability indicating potential of HPLC testing method for detection of Rifaximin in formulated tablets to be employed for quality control and stability testing. The questioned method applied with mobile phase methanol: water (70:30), 5µm, 250 x 4.6mm, C18 column, wavelength 293nm and flow rate of 1.0 ml/min. Forced degradation study was performed under oxidative, acidic, basic, thermal and photolytic conditions. The applied method successfully determined the degradation products after acidic and basic degradation without interfering with Rifaximin detection. Therefore, the method was said to be stability indicating and can be applied for quality control and stability testing of Rifaxmin tablets during its shelf life.

Keywords: forced degradation, high-performance liquid chromatography, method validation, rifaximin, stability indicating method

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22418 Stability Indicating RP – HPLC Method Development, Validation and Kinetic Study for Amiloride Hydrochloride and Furosemide in Pharmaceutical Dosage Form

Authors: Jignasha Derasari, Patel Krishna M, Modi Jignasa G.

Abstract:

Chemical stability of pharmaceutical molecules is a matter of great concern as it affects the safety and efficacy of the drug product.Stability testing data provides the basis to understand how the quality of a drug substance and drug product changes with time under the influence of various environmental factors. Besides this, it also helps in selecting proper formulation and package as well as providing proper storage conditions and shelf life, which is essential for regulatory documentation. The ICH guideline states that stress testing is intended to identify the likely degradation products which further help in determination of the intrinsic stability of the molecule and establishing degradation pathways, and to validate the stability indicating procedures. A simple, accurate and precise stability indicating RP- HPLC method was developed and validated for simultaneous estimation of Amiloride Hydrochloride and Furosemide in tablet dosage form. Separation was achieved on an Phenomenexluna ODS C18 (250 mm × 4.6 mm i.d., 5 µm particle size) by using a mobile phase consisting of Ortho phosphoric acid: Acetonitrile (50:50 %v/v) at a flow rate of 1.0 ml/min (pH 3.5 adjusted with 0.1 % TEA in Water) isocratic pump mode, Injection volume 20 µl and wavelength of detection was kept at 283 nm. Retention time for Amiloride Hydrochloride and Furosemide was 1.810 min and 4.269 min respectively. Linearity of the proposed method was obtained in the range of 40-60 µg/ml and 320-480 µg/ml and Correlation coefficient was 0.999 and 0.998 for Amiloride hydrochloride and Furosemide, respectively. Forced degradation study was carried out on combined dosage form with various stress conditions like hydrolysis (acid and base hydrolysis), oxidative and thermal conditions as per ICH guideline Q2 (R1). The RP- HPLC method has shown an adequate separation for Amiloride hydrochloride and Furosemide from its degradation products. Proposed method was validated as per ICH guidelines for specificity, linearity, accuracy; precision and robustness for estimation of Amiloride hydrochloride and Furosemide in commercially available tablet dosage form and results were found to be satisfactory and significant. The developed and validated stability indicating RP-HPLC method can be used successfully for marketed formulations. Forced degradation studies help in generating degradants in much shorter span of time, mostly a few weeks can be used to develop the stability indicating method which can be applied later for the analysis of samples generated from accelerated and long term stability studies. Further, kinetic study was also performed for different forced degradation parameters of the same combination, which help in determining order of reaction.

Keywords: amiloride hydrochloride, furosemide, kinetic study, stability indicating RP-HPLC method validation

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22417 Bioanalytical Method Development and Validation of Aminophylline in Rat Plasma Using Reverse Phase High Performance Liquid Chromatography: An Application to Preclinical Pharmacokinetics

Authors: S. G. Vasantharaju, Viswanath Guptha, Raghavendra Shetty

Abstract:

Introduction: Aminophylline is a methylxanthine derivative belonging to the class bronchodilator. From the literature survey, reported methods reveals the solid phase extraction and liquid liquid extraction which is highly variable, time consuming, costly and laborious analysis. Present work aims to develop a simple, highly sensitive, precise and accurate high-performance liquid chromatography method for the quantification of Aminophylline in rat plasma samples which can be utilized for preclinical studies. Method: Reverse Phase high-performance liquid chromatography method. Results: Selectivity: Aminophylline and the internal standard were well separated from the co-eluted components and there was no interference from the endogenous material at the retention time of analyte and the internal standard. The LLOQ measurable with acceptable accuracy and precision for the analyte was 0.5 µg/mL. Linearity: The developed and validated method is linear over the range of 0.5-40.0 µg/mL. The coefficient of determination was found to be greater than 0.9967, indicating the linearity of this method. Accuracy and precision: The accuracy and precision values for intra and inter day studies at low, medium and high quality control samples concentrations of aminophylline in the plasma were within the acceptable limits Extraction recovery: The method produced consistent extraction recovery at all 3 QC levels. The mean extraction recovery of aminophylline was 93.57 ± 1.28% while that of internal standard was 90.70 ± 1.30%. Stability: The results show that aminophylline is stable in rat plasma under the studied stability conditions and that it is also stable for about 30 days when stored at -80˚C. Pharmacokinetic studies: The method was successfully applied to the quantitative estimation of aminophylline rat plasma following its oral administration to rats. Discussion: Preclinical studies require a rapid and sensitive method for estimating the drug concentration in the rat plasma. The method described in our article includes a simple protein precipitation extraction technique with ultraviolet detection for quantification. The present method is simple and robust for fast high-throughput sample analysis with less analysis cost for analyzing aminophylline in biological samples. In this proposed method, no interfering peaks were observed at the elution times of aminophylline and the internal standard. The method also had sufficient selectivity, specificity, precision and accuracy over the concentration range of 0.5 - 40.0 µg/mL. An isocratic separation technique was used underlining the simplicity of the presented method.

Keywords: Aminophyllin, preclinical pharmacokinetics, rat plasma, RPHPLC

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22416 Stability Indicating Method Development and Validation for Estimation of Antiasthmatic Drug in Combined Dosages Formed by RP-HPLC

Authors: Laxman H. Surwase, Lalit V. Sonawane, Bhagwat N. Poul

Abstract:

A simple stability indicating high performance liquid chromatographic method has been developed for the simultaneous determination of Levosalbutamol Sulphate and Ipratropium Bromide in bulk and pharmaceutical dosage form using reverse phase Zorbax Eclipse Plus C8 column (250mm×4.6mm), with mobile phase phosphate buffer (0.05M KH2PO4): acetonitrile (55:45v/v) pH 3.5 adjusted with ortho-phosphoric acid, the flow rate was 1.0 mL/min and the detection was carried at 212 nm. The retention times of Levosalbutamol Sulphate and Ipratropium Bromide were 2.2007 and 2.6611 min respectively. The correlation coefficient of Levosalbutamol Sulphate and Ipratropium Bromide was found to be 0.997 and 0.998.Calibration plots were linear over the concentration ranges 10-100µg/mL for both Levosalbutamol Sulphate and Ipratropium Bromide. The LOD and LOQ of Levosalbutamol Sulphate were 2.520µg/mL and 7.638µg/mL while for Ipratropium Bromide was 1.201µg/mL and 3.640 µg/mL. The accuracy of the proposed method was determined by recovery studies and found to be 100.15% for Levosalbutamol Sulphate and 100.19% for Ipratropium Bromide respectively. The method was validated for accuracy, linearity, sensitivity, precision, robustness, system suitability. The proposed method could be utilized for routine analysis of Levosalbutamol Sulphate and Ipratropium Bromide in bulk and pharmaceutical capsule dosage form.

Keywords: levosalbutamol sulphate, ipratropium bromide, RP-HPLC, phosphate buffer, acetonitrile

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22415 Stability-Indicating High-Performance Thin-Layer Chromatography Method for Estimation of Naftopidil

Authors: P. S. Jain, K. D. Bobade, S. J. Surana

Abstract:

A simple, selective, precise and Stability-indicating High-performance thin-layer chromatographic method for analysis of Naftopidil both in a bulk and in pharmaceutical formulation has been developed and validated. The method employed, HPTLC aluminium plates precoated with silica gel as the stationary phase. The solvent system consisted of hexane: ethyl acetate: glacial acetic acid (4:4:2 v/v). The system was found to give compact spot for Naftopidil (Rf value of 0.43±0.02). Densitometric analysis of Naftopidil was carried out in the absorbance mode at 253 nm. The linear regression analysis data for the calibration plots showed good linear relationship with r2=0.999±0.0001 with respect to peak area in the concentration range 200-1200 ng per spot. The method was validated for precision, recovery and robustness. The limits of detection and quantification were 20.35 and 61.68 ng per spot, respectively. Naftopidil was subjected to acid and alkali hydrolysis, oxidation and thermal degradation. The drug undergoes degradation under acidic, basic, oxidation and thermal conditions. This indicates that the drug is susceptible to acid, base, oxidation and thermal conditions. The degraded product was well resolved from the pure drug with significantly different Rf value. Statistical analysis proves that the method is repeatable, selective and accurate for the estimation of investigated drug. The proposed developed HPTLC method can be applied for identification and quantitative determination of Naftopidil in bulk drug and pharmaceutical formulation.

Keywords: naftopidil, HPTLC, validation, stability, degradation

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22414 Near-Infrared Spectrometry as an Alternative Method for Determination of Oxidation Stability for Biodiesel

Authors: R. Velvarska, A. Vrablik, M. Fiedlerova, R. Cerny

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Near-infrared spectrometry (NIR) was tested as a rapid and alternative tool for determination of biodiesel oxidation stability. A PetroOxy method is standardly used for the determination, but this method is hazardous due to the possibility of explosion and ignition of flammable fuels. The second disadvantage is time consuming. The near-infrared spectrometry served for the development of the calibration model which was composed of 133 real samples (calibration standards). The reference values of these standards were obtained by PetroOxy method. Many chemometric diagnostics were used for the development of the final NIR model with the aim to have accurate prediction of the oxidation stability. The final NIR model was validated by 30 validation standards. The repeatability was determined as well with the acceptable residual standard deviation (8.59 %). The NIR spectrometry has proved to be an accurate alternative method for the determination of biodiesel oxidation stability with advantages as the time and cost saving, non-destructive character of analyzing and the possibility of online monitoring in safe mode.

Keywords: biodiesel, fatty acid methyl ester, NIR, oxidation stability

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22413 RP-HPLC Method Development and Its Validation for Simultaneous Estimation of Metoprolol Succinate and Olmesartan Medoxomil Combination in Bulk and Tablet Dosage Form

Authors: S. Jain, R. Savalia, V. Saini

Abstract:

A simple, accurate, precise, sensitive and specific RP-HPLC method was developed and validated for simultaneous estimation of Metoprolol Succinate and Olmesartan Medoxomil in bulk and tablet dosage form. The RP-HPLC method has shown adequate separation for Metoprolol Succinate and Olmesartan Medoxomil from its degradation products. The separation was achieved on a Phenomenex luna ODS C18 (250mm X 4.6mm i.d., 5μm particle size) with an isocratic mixture of acetonitrile: 50mM phosphate buffer pH 4.0 adjusted with glacial acetic acid in the ratio of 55:45 v/v. The mobile phase at a flow rate of 1.0ml/min, Injection volume 20μl and wavelength of detection was kept at 225nm. The retention time for Metoprolol Succinate and Olmesartan Medoxomil was 2.451±0.1min and 6.167±0.1min, respectively. The linearity of the proposed method was investigated in the range of 5-50μg/ml and 2-20μg/ml for Metoprolol Succinate and Olmesartan Medoxomil, respectively. Correlation coefficient was 0.999 and 0.9996 for Metoprolol Succinate and Olmesartan Medoxomil, respectively. The limit of detection was 0.2847μg/ml and 0.1251μg/ml for Metoprolol Succinate and Olmesartan Medoxomil, respectively and the limit of quantification was 0.8630μg/ml and 0.3793μg/ml for Metoprolol and Olmesartan, respectively. Proposed methods were validated as per ICH guidelines for linearity, accuracy, precision, specificity and robustness for estimation of Metoprolol Succinate and Olmesartan Medoxomil in commercially available tablet dosage form and results were found to be satisfactory. Thus the developed and validated stability indicating method can be used successfully for marketed formulations.

Keywords: metoprolol succinate, olmesartan medoxomil, RP-HPLC method, validation, ICH

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22412 Invention of Novel Technique of Process Scale Up by Using Solid Dosage Form

Authors: Shashank Tiwari, S. P. Mahapatra

Abstract:

The aim of this technique is to reduce the steps of process scales up, save time & cost of the industries. This technique will minimise the steps of process scale up. The new steps are, Novel Lab Scale, Novel Lab Scale Trials, Novel Trial Batches, Novel Exhibit Batches, Novel Validation Batches. In these steps, it is not divided to validation batches in three parts but the data of trials batches, Exhibit Batches and Validation batches are use and compile for production and used for validation. It also increases the batch size of the trial, exhibit batches. The new size of trials batches is not less than fifty Thousand, the exhibit batches increase up to two lack and the validation batches up to five lack. After preparing the batches all their data & drugs use for stability & maintain the validation record and compile data for the technology transfer in production department for preparing the marketed size batches.

Keywords: batches, technique, preparation, scale up, validation

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22411 Performance of the Strong Stability Method in the Univariate Classical Risk Model

Authors: Safia Hocine, Zina Benouaret, Djamil A¨ıssani

Abstract:

In this paper, we study the performance of the strong stability method of the univariate classical risk model. We interest to the stability bounds established using two approaches. The first based on the strong stability method developed for a general Markov chains. The second approach based on the regenerative processes theory . By adopting an algorithmic procedure, we study the performance of the stability method in the case of exponential distribution claim amounts. After presenting numerically and graphically the stability bounds, an interpretation and comparison of the results have been done.

Keywords: Marcov chain, regenerative process, risk model, ruin probability, strong stability

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22410 Global Stability Of Nonlinear Itô Equations And N. V. Azbelev's W-method

Authors: Arcady Ponosov., Ramazan Kadiev

Abstract:

The work studies the global moment stability of solutions of systems of nonlinear differential Itô equations with delays. A modified regularization method (W-method) for the analysis of various types of stability of such systems, based on the choice of the auxiliaryequations and applications of the theory of positive invertible matrices, is proposed and justified. Development of this method for deterministic functional differential equations is due to N.V. Azbelev and his students. Sufficient conditions for the moment stability of solutions in terms of the coefficients for sufficiently general as well as specific classes of Itô equations are given.

Keywords: asymptotic stability, delay equations, operator methods, stochastic noise

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22409 Direct Transient Stability Assessment of Stressed Power Systems

Authors: E. Popov, N. Yorino, Y. Zoka, Y. Sasaki, H. Sugihara

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This paper discusses the performance of critical trajectory method (CTrj) for power system transient stability analysis under various loading settings and heavy fault condition. The method obtains Controlling Unstable Equilibrium Point (CUEP) which is essential for estimation of power system stability margins. The CUEP is computed by applying the CTrjto the boundary controlling unstable equilibrium point (BCU) method. The Proposed method computes a trajectory on the stability boundary that starts from the exit point and reaches CUEP under certain assumptions. The robustness and effectiveness of the method are demonstrated via six power system models and five loading conditions. As benchmark is used conventional simulation method whereas the performance is compared with and BCU Shadowing method.

Keywords: power system, transient stability, critical trajectory method, energy function method

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22408 Model Predictive Controller for Pasteurization Process

Authors: Tesfaye Alamirew Dessie

Abstract:

Our study focuses on developing a Model Predictive Controller (MPC) and evaluating it against a traditional PID for a pasteurization process. Utilizing system identification from the experimental data, the dynamics of the pasteurization process were calculated. Using best fit with data validation, residual, and stability analysis, the quality of several model architectures was evaluated. The validation data fit the auto-regressive with exogenous input (ARX322) model of the pasteurization process by roughly 80.37 percent. The ARX322 model structure was used to create MPC and PID control techniques. After comparing controller performance based on settling time, overshoot percentage, and stability analysis, it was found that MPC controllers outperform PID for those parameters.

Keywords: MPC, PID, ARX, pasteurization

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22407 Strict Stability of Fuzzy Differential Equations by Lyapunov Functions

Authors: Mustafa Bayram Gücen, Coşkun Yakar

Abstract:

In this study, we have investigated the strict stability of fuzzy differential systems and we compare the classical notion of strict stability criteria of ordinary differential equations and the notion of strict stability of fuzzy differential systems. In addition that, we present definitions of stability and strict stability of fuzzy differential equations and also we have some theorems and comparison results. Strict Stability is a different stability definition and this stability type can give us an information about the rate of decay of the solutions. Lyapunov’s second method is a standard technique used in the study of the qualitative behavior of fuzzy differential systems along with a comparison result that allows the prediction of behavior of a fuzzy differential system when the behavior of the null solution of a fuzzy comparison system is known. This method is a usefull for investigating strict stability of fuzzy systems. First of all, we present definitions and necessary background material. Secondly, we discuss and compare the differences between the classical notion of stability and the recent notion of strict stability. And then, we have a comparison result in which the stability properties of the null solution of the comparison system imply the corresponding stability properties of the fuzzy differential system. Consequently, we give the strict stability results and a comparison theorem. We have used Lyapunov second method and we have proved a comparison result with scalar differential equations.

Keywords: fuzzy systems, fuzzy differential equations, fuzzy stability, strict stability

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22406 An UHPLC (Ultra High Performance Liquid Chromatography) Method for the Simultaneous Determination of Norfloxacin, Metronidazole, and Tinidazole Using Monolithic Column-Stability Indicating Application

Authors: Asmaa Mandour, Ramzia El-Bagary, Asmaa El-Zaher, Ehab Elkady

Abstract:

Background: An UHPLC (ultra high performance liquid chromatography) method for the simultaneous determination of norfloxacin (NOR), metronidazole (MET) and tinidazole (TNZ) using monolithic column is presented. Purpose: The method is considered an environmentally friendly method with relatively low organic composition of the mobile phase. Methods: The chromatographic separation was performed using Phenomenex® Onyex Monolithic C18 (50mmx 20mm) column. An elution program of mobile phase consisted of 0.5% aqueous phosphoric acid : methanol (85:15, v/v). Where elution of all drugs was completed within 3.5 min with 1µL injection volume. The UHPLC method was applied for the stability indication of NOR in the presence of its acid degradation product ND. Results: Retention times were 0.69, 1.19 and 3.23 min for MET, TNZ and NOR, respectively. While ND retention time was 1.06 min. Linearity, accuracy, and precision were acceptable over the concentration range of 5-50µg mL-1for all drugs. Conclusions: The method is simple, sensitive and suitable for the routine quality control and dosage form assay of the three drugs and can also be used for the stability indication of NOR in the presence of its acid degradation product.

Keywords: antibacterial, monolithic cilumn, simultaneous determination, UHPLC

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22405 Development of a Predictive Model to Prevent Financial Crisis

Authors: Tengqin Han

Abstract:

Delinquency has been a crucial factor in economics throughout the years. Commonly seen in credit card and mortgage, it played one of the crucial roles in causing the most recent financial crisis in 2008. In each case, a delinquency is a sign of the loaner being unable to pay off the debt, and thus may cause a lost of property in the end. Individually, one case of delinquency seems unimportant compared to the entire credit system. China, as an emerging economic entity, the national strength and economic strength has grown rapidly, and the gross domestic product (GDP) growth rate has remained as high as 8% in the past decades. However, potential risks exist behind the appearance of prosperity. Among the risks, the credit system is the most significant one. Due to long term and a large amount of balance of the mortgage, it is critical to monitor the risk during the performance period. In this project, about 300,000 mortgage account data are analyzed in order to develop a predictive model to predict the probability of delinquency. Through univariate analysis, the data is cleaned up, and through bivariate analysis, the variables with strong predictive power are detected. The project is divided into two parts. In the first part, the analysis data of 2005 are split into 2 parts, 60% for model development, and 40% for in-time model validation. The KS of model development is 31, and the KS for in-time validation is 31, indicating the model is stable. In addition, the model is further validation by out-of-time validation, which uses 40% of 2006 data, and KS is 33. This indicates the model is still stable and robust. In the second part, the model is improved by the addition of macroeconomic economic indexes, including GDP, consumer price index, unemployment rate, inflation rate, etc. The data of 2005 to 2010 is used for model development and validation. Compared with the base model (without microeconomic variables), KS is increased from 41 to 44, indicating that the macroeconomic variables can be used to improve the separation power of the model, and make the prediction more accurate.

Keywords: delinquency, mortgage, model development, model validation

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22404 Development and Validation of HPLC Method on Determination of Acesulfame-K in Jelly Drink Product

Authors: Candra Irawan, David Yudianto, Ahsanu Nadiyya, Dewi Anna Br Sitepu, Hanafi, Erna Styani

Abstract:

Jelly drink was produced from a combination of both natural and synthetic materials, such as acesulfame potassium (acesulfame-K) as synthetic sweetener material. Acesulfame-K content in jelly drink could be determined by High-Performance Liquid Chromatography (HPLC), but this method needed validation due to having a change on the reagent addition step which skips the carrez addition and comparison of mix mobile phase (potassium dihydrogen phosphate and acetonitrile) with ratio from 75:25 to 90:10 to be more efficient and cheap. This study was conducted to evaluate the performance of determination method for acesulfame-K content in the jelly drink by HPLC. The method referred to Deutsches Institut fur Normung European Standard International Organization for Standardization (DIN EN ISO):12856 (1999) about Foodstuffs, Determination of acesulfame-K, aspartame and saccharin. The result of the correlation coefficient value (r) on the linearity test was 0.9987 at concentration range 5-100 mg/L. Detection limit value was 0.9153 ppm, while the quantitation limit value was 1.1932 ppm. The recovery (%) value on accuracy test for sample concentration by spiking 100 mg/L was 102-105%. Relative Standard Deviation (RSD) value for precision and homogenization tests were 2.815% and 4.978%, respectively. Meanwhile, the comparative and stability tests were tstat (0.136) < ttable (2.101) and |µ1-µ2| (1.502) ≤ 0.3×CV Horwitz. Obstinacy test value was tstat < ttable. It can be concluded that the HPLC  method for the determination of acesulfame-K in jelly drink product by HPLC has been valid and can be used for analysis with good performance.

Keywords: acesulfame-K, jelly drink, HPLC, validation

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22403 Tomato Peels Prevented Margarine and Soya/Sunflower Oils Oxidation

Authors: S. Zidani, A. Benakmoum, A. Mansouri, A. Ammouche

Abstract:

In this research paper, we studied the oxidative stability of table margarine and soya/sunflower oils rich in lycopene with tomato peel powder (TPP). For this 1%, 2%, and 3% (w/w) of TPP was added to oil used in margarine manufacture. Chromatic characteristics of margarine and soya/sunflower oil have been studied using 'Tristimulus Colorimetry' method. The main point of the research was to determine the antioxidant activity and the oxidative resistance of soya/sunflower and margarine with TPP (peroxide index, TBA index, and rancimat test). The sensory and textural properties, overall acceptability of margarine and oil were good, indicating that TPP could be added to oil to produce a margarine enriched in lycopene with excellent stability oxidative.

Keywords: tomato peel powder, lycopene, table margarine, soya/sunflower oils, antioxidant activity, stability oxidative

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22402 Development and Validation of a HPLC Method for Standardization of Methanolic Extract of Hypericum sinaicum Hochst

Authors: Taghreed A. Ibrahim, Atef A. El-Hela, Hala M. El-Hefnawy

Abstract:

The chromatographic profile of methanol extract of Hypericum sinaicum was determined using HPLC-DAD. Apigenin was used as an external standard in the development and validation of the HPLC method. The proposed method is simple, rapid and reliable and can be successfully applied for standardization of Hypericum sinaicum methanol extract.

Keywords: quality control, standardization, falvonoids, methanol extract

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22401 Hardware Implementation and Real-time Experimental Validation of a Direction of Arrival Estimation Algorithm

Authors: Nizar Tayem, AbuMuhammad Moinuddeen, Ahmed A. Hussain, Redha M. Radaydeh

Abstract:

This research paper introduces an approach for estimating the direction of arrival (DOA) of multiple RF noncoherent sources in a uniform linear array (ULA). The proposed method utilizes a Capon-like estimation algorithm and incorporates LU decomposition to enhance the accuracy of DOA estimation while significantly reducing computational complexity compared to existing methods like the Capon method. Notably, the proposed method does not require prior knowledge of the number of sources. To validate its effectiveness, the proposed method undergoes validation through both software simulations and practical experimentation on a prototype testbed constructed using a software-defined radio (SDR) platform and GNU Radio software. The results obtained from MATLAB simulations and real-time experiments provide compelling evidence of the proposed method's efficacy.

Keywords: DOA estimation, real-time validation, software defined radio, computational complexity, Capon's method, GNU radio

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22400 An Enhanced Approach in Validating Analytical Methods Using Tolerance-Based Design of Experiments (DoE)

Authors: Gule Teri

Abstract:

The effective validation of analytical methods forms a crucial component of pharmaceutical manufacturing. However, traditional validation techniques can occasionally fail to fully account for inherent variations within datasets, which may result in inconsistent outcomes. This deficiency in validation accuracy is particularly noticeable when quantifying low concentrations of active pharmaceutical ingredients (APIs), excipients, or impurities, introducing a risk to the reliability of the results and, subsequently, the safety and effectiveness of the pharmaceutical products. In response to this challenge, we introduce an enhanced, tolerance-based Design of Experiments (DoE) approach for the validation of analytical methods. This approach distinctly measures variability with reference to tolerance or design margins, enhancing the precision and trustworthiness of the results. This method provides a systematic, statistically grounded validation technique that improves the truthfulness of results. It offers an essential tool for industry professionals aiming to guarantee the accuracy of their measurements, particularly for low-concentration components. By incorporating this innovative method, pharmaceutical manufacturers can substantially advance their validation processes, subsequently improving the overall quality and safety of their products. This paper delves deeper into the development, application, and advantages of this tolerance-based DoE approach and demonstrates its effectiveness using High-Performance Liquid Chromatography (HPLC) data for verification. This paper also discusses the potential implications and future applications of this method in enhancing pharmaceutical manufacturing practices and outcomes.

Keywords: tolerance-based design, design of experiments, analytical method validation, quality control, biopharmaceutical manufacturing

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22399 Analytical Formulae for Parameters Involved in Side Slopes of Embankments Stability

Authors: Abdulrahman Abdulrahman, Abir Abdulrahman

Abstract:

The stability of slopes of earthen embankments is usually examined by Swedish slip circle method or the slices method. The factor of safety against sliding using Fellenius procedure depends upon the angle formed by the arc of sliding at the center ψ and the radius of the slip circle r. The values of both mentioned parameters ψ and r aren't precisely predicted because they are measured from the drawing. In this paper, analytical formulae were derived for finding the exact values of both ψ and r. Also this paper presents the different conditions of intersections the slip circle with the body of an earthen dam and the coordinate of intersection points. Numerical examples are chosen for demonstration the proposed solution

Keywords: earthen dams stability, , earthen embankments stability, , Fellenius method, hydraulic structures, , side slopes stability, , slices method, Swedish slip circle

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22398 Semi-Automatic Method to Assist Expert for Association Rules Validation

Authors: Amdouni Hamida, Gammoudi Mohamed Mohsen

Abstract:

In order to help the expert to validate association rules extracted from data, some quality measures are proposed in the literature. We distinguish two categories: objective and subjective measures. The first one depends on a fixed threshold and on data quality from which the rules are extracted. The second one consists on providing to the expert some tools in the objective to explore and visualize rules during the evaluation step. However, the number of extracted rules to validate remains high. Thus, the manually mining rules task is very hard. To solve this problem, we propose, in this paper, a semi-automatic method to assist the expert during the association rule's validation. Our method uses rule-based classification as follow: (i) We transform association rules into classification rules (classifiers), (ii) We use the generated classifiers for data classification. (iii) We visualize association rules with their quality classification to give an idea to the expert and to assist him during validation process.

Keywords: association rules, rule-based classification, classification quality, validation

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22397 A Validation Technique for Integrated Ontologies

Authors: Neli P. Zlatareva

Abstract:

Ontology validation is an important part of web applications’ development, where knowledge integration and ontological reasoning play a fundamental role. It aims to ensure the consistency and correctness of ontological knowledge and to guarantee that ontological reasoning is carried out in a meaningful way. Existing approaches to ontology validation address more or less specific validation issues, but the overall process of validating web ontologies has not been formally established yet. As the size and the number of web ontologies continue to grow, the necessity to validate and ensure their consistency and interoperability is becoming increasingly important. This paper presents a validation technique intended to test the consistency of independent ontologies utilized by a common application.

Keywords: knowledge engineering, ontological reasoning, ontology validation, semantic web

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22396 Development of Lipid Architectonics for Improving Efficacy and Ameliorating the Oral Bioavailability of Elvitegravir

Authors: Bushra Nabi, Saleha Rehman, Sanjula Baboota, Javed Ali

Abstract:

Aim: The objective of research undertaken is analytical method validation (HPLC method) of an anti-HIV drug Elvitegravir (EVG). Additionally carrying out the forced degradation studies of the drug under different stress conditions to determine its stability. It is envisaged in order to determine the suitable technique for drug estimation, which would be employed in further research. Furthermore, comparative pharmacokinetic profile of the drug from lipid architectonics and drug suspension would be obtained post oral administration. Method: Lipid Architectonics (LA) of EVR was formulated using probe sonication technique and optimized using QbD (Box-Behnken design). For the estimation of drug during further analysis HPLC method has been validation on the parameters (Linearity, Precision, Accuracy, Robustness) and Limit of Detection (LOD) and Limit of Quantification (LOQ) has been determined. Furthermore, HPLC quantification of forced degradation studies was carried out under different stress conditions (acid induced, base induced, oxidative, photolytic and thermal). For pharmacokinetic (PK) study, Albino Wistar rats were used weighing between 200-250g. Different formulations were given per oral route, and blood was collected at designated time intervals. A plasma concentration profile over time was plotted from which the following parameters were determined:

Keywords: AIDS, Elvitegravir, HPLC, nanostructured lipid carriers, pharmacokinetics

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22395 Specific Emitter Identification Based on Refined Composite Multiscale Dispersion Entropy

Authors: Shaoying Guo, Yanyun Xu, Meng Zhang, Weiqing Huang

Abstract:

The wireless communication network is developing rapidly, thus the wireless security becomes more and more important. Specific emitter identification (SEI) is an vital part of wireless communication security as a technique to identify the unique transmitters. In this paper, a SEI method based on multiscale dispersion entropy (MDE) and refined composite multiscale dispersion entropy (RCMDE) is proposed. The algorithms of MDE and RCMDE are used to extract features for identification of five wireless devices and cross-validation support vector machine (CV-SVM) is used as the classifier. The experimental results show that the total identification accuracy is 99.3%, even at low signal-to-noise ratio(SNR) of 5dB, which proves that MDE and RCMDE can describe the communication signal series well. In addition, compared with other methods, the proposed method is effective and provides better accuracy and stability for SEI.

Keywords: cross-validation support vector machine, refined com- posite multiscale dispersion entropy, specific emitter identification, transient signal, wireless communication device

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22394 Study of Stability of a Slope by the Soil Nailed Technique

Authors: Abdelhak Soudani

Abstract:

Using the limit equilibrium method in geotechnical field is very important for large projects. This work contributes to the understanding and analysis of the building unstable slopes by the technique of soil nailed with the used of software called GEO-SLOPE calculation based on limit equilibrium method. To achieve our objective, we began a review of the literature on landslides, and techniques of slope stability. Then, we presented a real case slope likely to slip through the realization of the EastWest Highway (M5 stretch between Khemis Miliana and Hoceinia). We also process the application of reinforcement technique nailed soil. The analysis is followed by a parametric study, which shows the impact of parameters given or chosen on various outcomes. Another method of reinforcement (use of micro-piles) has been suggested for improving the stability of the slope

Keywords: slope stability, strengthening, slip, soil nail, GEO-SLOPE

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22393 An Implicit Methodology for the Numerical Modeling of Locally Inextensible Membranes

Authors: Aymen Laadhari

Abstract:

We present in this paper a fully implicit finite element method tailored for the numerical modeling of inextensible fluidic membranes in a surrounding Newtonian fluid. We consider a highly simplified version of the Canham-Helfrich model for phospholipid membranes, in which the bending force and spontaneous curvature are disregarded. The coupled problem is formulated in a fully Eulerian framework and the membrane motion is tracked using the level set method. The resulting nonlinear problem is solved by a Newton-Raphson strategy, featuring a quadratic convergence behavior. A monolithic solver is implemented, and we report several numerical experiments aimed at model validation and illustrating the accuracy of the proposed method. We show that stability is maintained for significantly larger time steps with respect to an explicit decoupling method.

Keywords: finite element method, level set, Newton, membrane

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22392 An Innovative Non-Invasive Method To Improve The Stability Of Orthodontic Implants: A Pilot Study

Authors: Dr., Suchita Daokar

Abstract:

Background: Successful orthodontic treatment has always relied on anchorage. The stability of the implants depends on bone quantity, mini-implant design, and placement conditions. Out of the various methods of gaining stability, Platelet concentrations are gaining popularity for various reasons. PRF is a minimally invasive method, and there are various studies that has shown its role in enhancing the stability of general implants. However, there is no literature found regarding the effect of PRF in enhancing the stability of the orthodontic implant. Therefore, this study aimed to evaluate and assess the efficacy of PRF on the stability of the orthodontic implant. Methods: The study comprised of 9 subjects aged above 18 years of age. The split mouth technique was used; Group A (where implants were coated before insertion) and group B (implant were normally inserted). The stability of the implant was measured using resonance frequency analysis at insertion (T0), 24 hours (T1), 2 weeks (T2), at 4 weeks (T3), at 6 weeks (T4), and 8 weeks (T5) after insertion. Result: Statistically significant findings were found when group A was compared to group B using ANOVA test (p<0.05). The stability of the implant of group A at each time interval was greater than group B. The implant stability was high at T0 and reduces at T2, and increasing through T3 to T5. The stability was highest at T5. Conclusion: A chairside, minimally invasive procedure ofPRF coating on implants have shown promising results in improving the stability of orthodontic implants and providing scope for future studies.

Keywords: Orthodontic implants, stablity, resonance Frequency Analysis, pre

Procedia PDF Downloads 172
22391 Method Development and Validation for Quantification of Active Content and Impurities of Clodinafop Propargyl and Its Enantiomeric Separation by High-Performance Liquid Chromatography

Authors: Kamlesh Vishwakarma, Bipul Behari Saha, Sunilkumar Sing, Abhishek Mishra, Sreenivas Rao

Abstract:

A rapid, sensitive and inexpensive method has been developed for complete analysis of Clodinafop Propargyl. Clodinafop Propargyl enantiomers were separated on chiral column, Chiral Pak AS-H (250 mm. 4.6mm x 5µm) with mobile phase n-hexane: IPA (96:4) at flow rate 1.5 ml/min. The effluent was monitored by UV detector at 230 nm. Clodinafop Propagyl content and impurity quantification was done with reverse phase HPLC. The present study describes a HPLC method using simple mobile phase for the quantification of Clodinafop Propargyl and its impurities. The method was validated and found to be accurate, precise, convenient and effective. Moreover, the lower solvent consumption along with short analytical run time led to a cost effective analytical method.

Keywords: Clodinafop Propargyl, method, validation, HPLC-UV

Procedia PDF Downloads 333