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 phosphate in 1000 ml of water (adjusted to 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 minutes, 22.06 minutes and 12.03 minutes respectively. The percentage recovery was within the range between 102.2 % and 103.23 % for Clindamycin phosphate, 98.96 % and 100.54 % for Clotrimazole. The linear ranges were found to be 200 mg / ml (r2 = 0.9998) for Clindamycin phosphate, 400 mg / ml (r2 = 0.9895) 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 mg / ml and correlation coefficient of were found to be 0.9998, 0.9979, 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.