Simultaneous estimation of Simvastatin and Ezetimibe in pharmaceutical formulations by RP-HPLC method

Abstract

Simvastatin and Ezetimibe are used to treat hyperlipidemia. A simple, precise cost effective and stability indicating RP-HPLC method has been developed and validated for the simultaneous determination of Simvastatin and Ezetimibe in pharmaceutical formulations. Separation of both simvastatin and Ezetimibe was achived with in 5 minutes with required resolution, accuracy and precision thus enabling the utility of the method for routine analysis. Chromatographic separation was achieved on a X-terra RP-18 column(50 x 4.6 mm, 5μ) using a mobile phase consisting of 0.05M phosphate buffer pH3.0 and Acetonitrile in the ratio of 45:55 at a flow rate of 0.8ml per minute. The detection was made at 236nm. The retention time of Simvastatin and Ezetimibe were 3.3 and 0.8 minutes respectively. The method was found linear over the range of 5-15 μg per ml for Ezetimibe and 40-120 μg per ml for Simvavastatin. The proposed method was validated as per the ICH and USP guidelines.