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DEVELOPMENT AND VALIDATION OF HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE IN GEL FORMULATION

Abstract

Madhuri Sharma, Ankita Bhavsar

A simple, rapid and sensitive Reverse Phase High Performance Liquid Chromatography method was developed for simultaneous estimation of Clindamycin Phosphate and Benzoyl Peroxide in gel formulation by using BDS Phenomanax Luna C18 (150X4.6) mm, 5µ and 20mM Ammonium acetate buffer pH 4.0: Methanol (45:55% v/v) as mobile phase at flow rate of 1.2 ml/min with detection wavelength of 210nm. Retention times for Clindamycin Phosphate and Benzoyl Peroxide were 4.49 min, 8.78 min respectively. The linearity of developed method was achieved in the range of 10.0-30.0 µg/ml for Clindamycin Phosphate and 25.0-75.1 µg/ml for Benzoyl Peroxide and limit of detection was found to be 0.32 µg/ml and 0.72 µg/ml and limit of quantification was found to be 0.98 µg/ml and 2.19 µg/ml for Clindamycin Phosphate and Benzoyl Peroxide respectively. The % Recovery of Clindamycin Phosphate was found to be 98.45 % -101.0% and 99.8 % -99.38 % for Benzoyl Peroxide. In a precision the repeatability % RSD was found to be 0.4 for Clindamycin Phosphate and 0.3 for Benzoyl Peroxide. Change in the ratio of mobile phase ±2.0 ml, Change in flow rate by ±0.2 ml/minute, Change in pH of mobile phase by ± 0.2 . Specificity of the method was ascertained by analysing standard drug and sample. No interfering peaks were found in the chromatogram by the proposed RP-HPLC method.

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