RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF CLINDAMYCIN PHOSPHATE AND CLOTRIMAZOLE IN PHARMACEUTICAL DOSAGE FORMS

Abstract

A simple, efficient and reproducible Reverse Phase - High Performance Liquid Chromatography (RP - HPLC) method for simultaneous determination of Clindamycin phosphate and Clotrimazole in combined soft gelatin pessaries pharmaceutical formulation has been developed. The separation was carried out on Hypersil BDS C8 (250 × 4.6 mn; 5 µm) column using buffer , 13.6 g Potassium dihydrogen ortho phosphat e in 1000 ml of water (adjusted t o pH 2.5 ortho phosphoric acid) : acetonitrile: l in the ratio of 70:30 v/v as eluent. The flow rate was 1.0 ml / min and effluent was detected at 210 nm. The retention times of Clindamycin phosphate and Clotrimazole were 4. 47 min utes , 22.06 min utes and 12.03 min utes respectively. The percentage recovery was within the range between 102.2 % and 10 3 . 2 3 % for Clindamycin phosphate, 98.96 % and 1 00.54 % for Clotrimazole . The linear ranges were found to be 200 m g / ml (r 2 = 0. 999 8 ) for Clindamycin phosphate , 400 m g / ml (r 2 = 0.9 895 ) for Clotrimazole . The percentage relative standard deviation for accuracy and precision was found to be less than 2 %. The linearity was found to be in the range of 80 - 120 m g / ml and correlation coef ficient of were found to be 0.9998, 0.9 979 , for Clindamycin Phosphate, Clotrimazole respectively . The proposed method is accurate with 102 % recovery and precise (% RSD of Reproducibility repeatability, intra - day and inter - day variations were 0.19 , 0.24, 0 .44, 0.78, 0.12 - 0.15, 0.13 - 0.37 , 0.14, 0.22 ). The method was successfully applied to pharmaceutical formulation because no chromatographic interferences from peccaries excipients were found.