RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF NIACIN AND SIMVASTATIN IN TABLET DOSAGE FORM

A simple RP-HPLC method has been developed for the simultaneous estimation of Niacin and Simvastatin in tablet dosage form. Chromatographic separation was achieved on Hypersil BDS C18 (250 x 4.6 mm, 5µm column using Acetonitrile and Ammonium dihydrogen phosphate buffer in the ratio of 80:20 v/v, pH 5, with flow rate of 1 ml/min. The detection wavelength was set at 254 nm. The retention time of niacin was 2.0852 and simvastatin was found to be 5.7052. The method was applied to tablet dosage forms, without any interference from excipients. The calibration curve was linear over the range of 20-120 ug/ml. The performance of the method was validated according to ICH guidelines and it was found suitable for the analysis of Niacin and Simvastatin in tablet dosage forms. Keywords: Niacin, Simvastatin, RP-HPLC, Method Development, Validation, ICH guidelines.