Analytical RP-HPLC Method Development and Validation For Simultaneous Estimation of Simvastatin and Fenofibrate in Combination

Abstract

This work is perturbed with the implementation of a simple, accurate and precise RP-HPLC method for simultaneous estimation of Simvastatin and Fenofibrate in combined dosage form. Both drugs were estimated using Reverse Phase mode with the help of C-18 column ((HIQ Sil C18, 250mm x 4.6 mm, 5μm), using isocratic mobile phase containing mixtures of Acetonitrile, methanol and water in the ratio of (ACN: MeOH: Water) (30:40:30), with the flow rate of 1ml/min. the eluents were monitored at 238nm with the run time of 20 minutes. The mean retention times of Fenofibrate and Simvastatin was found to be 13.637 and 15.597 respectively. Fenofibrate and Simvastatin showed good linearity in the concentration range of 20-100μg/ml with the co-efficient (R2) of 0.9998 and 0.9994 respectively. The developed method was validated according to ICH guidelines. Parameters such as linearity, precision, LOD, LOQ and System suitability were performed and was found in the accordance within the prescribed values. Thus, this method was successfully applied for simultaneous determination of Simvastatin and Fenofibrate in the routine analysis of formulation.