RP-HPLC Method Development and Validation for the Simultaneous Estimation of Atorvastatin, Fenofibrate and Ezetimibe in a Pharmaceutical Dosage Form Swetha Chandrika Gurram* Department of

Abstract

A simple and selective LC method is described for the determination of Atorvastatin, Ezetimibe and Fenofibrate in tablet dosage forms. Chromatographic separation was achieved on a reversed-phase C18 column (Inertsil ODS 3 V, 5 μ, 250 mm × 4.6 mm) using mobile phase of a mixture of 80 volumes of Methanol: 10 volumes of Acetonitrile and 10 volumes of Water with detection of 256 nm. Linearity was observed in the range 3-7 μg/ml for Atorvastatin (r2=0.9985), 3-7 μg /ml for Ezetimibe (r2=0.9971) and 48-112 μg /ml for Fenofibrate (r2=0.9964) for the amount of drugs estimated by the proposed methods was in good agreement with the label claim. The results show that the method was found to be specific, simple, accurate, precise, sensitive and validated. The accuracy of the methods was assessed by recovery studies at three different levels. The method was found to be precise as indicated by the repeatability analysis, showing %RSD less than 2. The method was successfully applied for the determination of three drugs in combined tablet dosage form.