Stability indicating UPLC method for simultaneous determination of atorvastatin, fenofibrate and their degradation products in tablets

Abstract

A stability indicating UPLC method was developed and validated for the simultaneous determination of atorvastatin, fenofibrate and their impurities in tablets. The chromatographic separation was performed on acquity UPLC™ BEH C18 column (1.7 μm, 2.1 mm × 100 mm) using gradient elution of acetonitrile and ammonium acetate buffer (pH 4.7; 0.01 M) at flow rate of 0.5 ml/min. UV detection was performed at 247 nm. Total run time was 3 min within which main compounds and six other known and major unknown impurities were separated. Stability indicating capability was established by forced degradation experiments and separation of known degradation products. The method was validated for accuracy, repeatability, reproducibility and robustness. Linearity, LOD and LOQ was established for atorvastatin, fenofibrate and their known impurities.