Search results for: olmesartan medoxomil

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

Procedia PDF Downloads 315

Authors: Noha Ibrahim, Eman S. Elzanfaly, Said A. Hassan, Ahmed E. El Gendy

Abstract:

Objectives: The purpose of the study is to develop a sensitive synchronous spectrofluorimetric method with multivariate calibration after studying and optimizing the different variables affecting the native fluorescence intensity of amlodipine and olmesartan implementing an experimental design approach. Method: In the first step, the fractional factorial design used to screen independent factors affecting the intensity of both drugs. The objective of the second step was to optimize the method performance using a Central Composite Face-centred (CCF) design. The optimal experimental conditions obtained from this study were; a temperature of (15°C ± 0.5), the solvent of 0.05N HCl and methanol with a ratio of (90:10, v/v respectively), Δλ of 42 and the addition of 1.48 % surfactant providing a sensitive measurement of amlodipine and olmesartan. The resolution of the binary mixture with a multivariate calibration method has been accomplished mainly by using partial least squares (PLS) model. Results: The recovery percentage for amlodipine besylate and atorvastatin calcium in tablets dosage form were found to be (102 ± 0.24, 99.56 ± 0.10, for amlodipine and Olmesartan, respectively). Conclusion: Method is valid according to some International Conference on Harmonization (ICH) guidelines, providing to be linear over a range of 200-300, 500-1500 ng mL⁻¹ for amlodipine and Olmesartan. The methods were successful to estimate amlodipine besylate and olmesartan in bulk powder and pharmaceutical preparation.

Keywords: amlodipine, central composite face-centred design, experimental design, fractional factorial design, multivariate calibration, olmesartan

Procedia PDF Downloads 149