Journal of Chromatography & Separation Techniques
Open Access

Abstract

Development and Validation of Stability Indicating RP-UPLC Method for Simultaneous Determination in Fixed Dose Combination of Ezetimibe and Simvastatin

Seshukumar Devu, Abhishek Gupta, Kona S Srinivas, Ravi Shankar Gupta and Vinod Prasad Semwal

A stability indicating UPLC method was developed and validated for the simultaneous determination of fixed dose combination of ezetimibe and simvastatin in bulk drug. The developed method was successfully applied to the simultaneous quantitative analysis of the title drugs in tablet dosage form. The chromatographic separation was performed on Kromasil Eternity TM C 18 UHPLC column (2.5 μm, 2.1 mm x 50 mm) using gradient elution of acetonitrile and ammonium acetate buffer (pH 6.70; 0.01 M) as mobile phase at a flow rate of 0.35 mL/min and column oven temperature of 40ºC. UV detection was carried out using a UV-PDA detector at 235 nm. Total run time was 3.5 min within which main compounds and their degradation products were separated. The method was validated for accuracy, repeatability, reproducibility and robustness. Linearity, LOD and LOQ were established for ezetimibe and simvastatin.