Validated Simultaneous Estimation of Simvastatin and Ezetimibe by RP-HPLC in Pure and Pharmaceutical Dosage Form

Abstract

A simple, precise RP-HPLC method was developed for the estimation of ezetimibe and simvastatin in pure and pharmaceutical dosage forms. The quantification was carried out using a C-18 column 250 × 4.6 mm i.d., 5 μm particle size in isocratic mode, with mobile phase comprising of buffer and acetonitrile in the ratio of 45:55 (v/v) pH 7. The flow rate was 1 mL/min and the detection was carried out UV detector at 210 nm. The retention times were 12.06 and 18.97 min for ezetimibe and simvastatin, respectively. The method produced linear response in the concentration range of 25-125 μg/mL for ezetimibe and simvastatin. The percentage recovery was found to be 99.8 and 100 % for ezetimibe and simvastatin, respectively. Atorvastatin used as an internal standard in the present study. The method validated by evaluation of required parameters.