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Method Development and Validation for the Determination of Cefixime in Pure and Commercial Dosage Forms by Specrophotometry

Authors: S. N. H. Azmi, B. Iqbal, J. K. Al Mamari, K. A. Al Hattali, W. N. Al Hadhrami

Abstract:

A simple, accurate and precise direct spectrophotometric method has been developed for the determination of cefixime in tablets and capsules. The method is based on the reaction of cefixime with a mixture of potassium iodide and potassium iodate to form yellow coloured product in ethanol-distilled water medium at room temperature which absorbed maximally at 352 nm. The factors affecting the reaction product were carefully studied and optimized. The validation parameters based on International Conference on Harmonisation (ICH, USA) guidelines were followed. The effect of common excipients used as additives has been tested and the tolerance limit was calculated for the determination of cefixime. Beer’s law is obeyed in the concentration range of 4 – 24 ug mL-1 with apparent molar absorptivity of 1.52 × 104 L mol-1cm-1 and Sandell’s sensitivity of 0.033 ug/cm2/ 0.001 absorbance unit. The limits of detection and quantitation for the proposed method are 0.32 and 1.06 ug mL-1, respectively. The proposed method has been successfully applied for the determination of cefixime in pharmaceutical formulations. The results obtained by the proposed method were statistically compared with the reference method using t- and F- values and found no significant difference between the two methods. The proposed method can be used as an alternate method for routine quality control analysis of cefixime in pharmaceutical formulations.

Keywords: Validation, Pharmaceutical Formulations, spectrophotometry, cefixime

Digital Object Identifier (DOI): doi.org/10.5281/zenodo.1096675

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