UV SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS QUANTITATIVE ESTIMATION OF MEBEVERINE HYDROCHLORIDE AND CHLORDIAZEPOXIDE IN CAPSULES

摘要

Objective: To develop a simple and cheap UV spectrophotometric method for the simultaneous quantitative estimation of Mebeverine hydrochloride (135mg) and Chlordiazepoxide (5mg) in MEVA C Capsules and validate as per ICH guidelines. Methods: The optimized method uses a diluent 100% Triethylammonium phosphate buffer (pH 3.0) for the estimation of assay of Mebeverine hydrochloride and Chlordiazepoxide in Capsules which are analyzed at a detection wavelength of 260nm. Results: The developed method exhibited linearity in the range of 10-40μg/ml for Mebeverine hydrochloride and 2.5-10μg/ml for Chlordiazepoxide. The precision for Mebeverine hydrochloride and Chlordiazepoxide is exemplified by relative standard deviation of 0.499% and 1.75 respectively. Percentage Mean recovery for Mebeverine hydrochloride and Chlordiazepoxide were found to be in the range of 98‐102, during accuracy studies. The limit of detection (LOD) for Mebeverine hydrochloride and Chlordiazepoxide were found to be 321ng/ml and 3.7ng/ml respectively, while limit of quantitiation (LOQ) for Mebeverine hydrochloride and Chlordiazepoxide were found to be 973ng/ml and 11.2ng/ml respectively. Conclusion: A simple and a cheap UV spectrophotometric method was developed and validated for the simultaneous quantitative estimation of Mebeverine hydrochloride and Chlordiazepoxide in capsules as per ICH guidelines and hence it can be used for the routine analysis in various pharmaceutical industries. Keywords: UV, Mebeverine hydrochloride, Chlordiazepoxide, Method development, Validation