DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE ESTIMATION OF CHOLINE FENOFIBRATE IN BULK AND ITS PHARMACEUTICAL DOSAGE FORM

摘要

A simple and precise RP-HPLC method was developed and validated for the determination of Choline fenofibrate in pharmaceutical dosage forms. Chromatography was carried out on Agilent make Zorbax C₁₈ column (4.6 mm x 15 cm), 5 μ particle size using a mobile phase of phosphate buffer (pH 6.8) : acetonitrile (70 : 30 % v/v) at a flow rate of 0.8 ml/min. The analyte was monitored using UV detector at 298 nm. The retention time was found to be 3.207 min for Choline fenofibrate. The proposed method was found to be having linearity in the concentration range of 5-35 μg/ml with correlation coefficient 0.999. The mean recoveries obtained for Choline fenofibrate were in the range of 99.4-100.65 %. The developed method has been statistically validated according to ICH guidelines and found to be simple, precise and accurate with the prescribed values. Thus the proposed method was successfully applied for the estimation of Choline fenofibrate in routine quality control analysis in bulk and its formulations.