Microbiological Analytical Method for Determination of Sertaconazole Nitrate in Pharmaceutical Formulations

Abstract

Sertaconazole nitrate is a third generation synthetic broad-spectrum, benzothiophene imidazole antifungal agent. A new microbiological method was developed for analysis of sertaconazole tablets using candida Albicans as test microorganism. The diffusion assay method was optimized by using different media, organisms and conditions. Prospective validation of the method showed adequate linearity (r = 0.9964), precision (% RSD<2%) and accuracy (mean recovery = 98.26%). Highperformance liquid chromatography was chosen as a comparison method for voriconazole determination. Results of both the microbiological and HPLC methods were compared with student ttest and the contents of voriconazole determined by both methods, showed a strong correlation. Highperformance liquid chromatography was chosen as a comparison method. Results of both the microbiological and HPLC methods were compared with student t-test and the contents of sertaconazole determined by both methods showed a strong correlation. The microbiological analytical method which was developed gives true indication of biological activity and can be used for routine quality control analysis of sertaconazole nitrate in dosage forms. Key words: Sertaconazole nitrate, t-test, Candida albicans, Diffusion method, HPLC, Method validation.