Development of RP-HPLC Method for Determination of Ezetimibe and Fenofibrate from Synthetic Mixture

Author(s): S. Sambath Kumar, Suman Jain, S. Kannan, Rahul Dixit, Bhabatosh Halder and V. K. Rai

A simple precise, accurate and validated reverse phase HPLC method has been developed for the simultaneous estimation of ezetimibe and fenofibrate in bulk and in synthetic mixture using C18 column (Kromosil, 4.6 mm x 25 cm, 5 μm) with acetonitrile: 0.05 M ammonium acetate buffer (85 : 15 v/v) as a mobile phase, at a flow rate of 1.3 mL/min and detection was done at 253.0 nm. The retention time for ezetimibe and fenofibrate was found to be 2.41 ± 0.011 and 6.03 ± 0.023 min, respectively. Linearity of ezetimibe and fenofibrate was found in the range of 2-20 μg/mL and 16-80 μg/mL, respectively. The percentage assay of ezetimibe and fenofibrate was found between 99% to 101%. The statistical parameters were found within range.

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