A Simple and Validated RP-HPLC Method for the Simultaneous Determination of Ezetimibe and Fenofibrate in Bulk and Pharmaceutical Dosage forms

A reverse phase high performance liquid chromatographic method was developed for the simultaneous determination of Ezetimibe and Fenofibrate in bulk and pharmaceutical dosage forms. The determination was performed by using Waters Symmetry Inertsil ODS (250×4.6mm×5μ) as stationary phase and Methanol: Acetonitrile: Water in the ratio of (80:10: 10 %v/v/v) as mobile phase. The flow rate of mobile phase was optimized as 1mL/min and effluents were monitored at 251nm. The retention time of Ezetimibe and Fenofibrate were found as 3.23min and 6.48min respectively. The method shows linearity in the concentration range of 6-14 μg/mL and 87-203 μg/mL respectively. The developed method was validated for specificity, precision, linearity, accuracy, robustness, Ruggedness, LOD and LOQ. Recovery of Ezetimibe and Fenofibrate in formulations was found to be in the range of 98.07-101.94% and 98.45-101.40% respectively conforms the non-interferences of the excepients in the formulation. Due to its simplicity, rapidness and high precision, the proposed RP- HPLC method can be used for the simultaneous determination of these two drugs in Quality control department for regular analysis.