Quantification and Validation of Simvastatin and Ezetimibe in Bulk Drugs and Combined Dosage Form by Reverse Phase Liquid Chromatographic Method (RPLC)

摘要

A simple, time saving, precise and cost effective reverse phase high performanceliquid chromatographic (RP-HPLC) method developement wasachieved for the determination and estimation of simvastatin and ezetimibein its pure form and combined formulation. Separation was achieved byusing Zorbax (100 × 4.6 mm, 5μ) C18 column with mobile phase consistedof acetonitrile and methanol in a ratio of 60:40 (v/v). The separation wasobserved at 232 nm with flow rate adjusted to 1 ml/min .simvastatin andezetimibe were retained at 9.603 and 3.861 minutes successively. Validationwas done for the developed method based upon different parameters likelinearity, accuracy, precision, limit of detection and limit of quantitation.Simvastatin and ezetimibe obey Beer-Lambert’s law in the range of20.0-160 μg/ml and 5-40 μg/ml respectively. The % recoveries of simvastatinand ezetimibe were found to be 101.25% and 102.03% respectivelyfrom the tablet formulation. The limit of detection of simvastatin and ezetimibewere found to be 1.34 μg/ml and 0.253 μg/ml successively. The limitof quantitation of simvastatin and ezetimibe were found to be 4.489 μg/ml and 0.846 μg/ml successively. The established method is suitable forsimultaneous estimation of simvastatin and ezetimibe in their pure formsand combined formulation.