Simultaneous Determination and Validation of Pitavastatin Calcium and Ezetimibe in Binary Mixture by Liquid Chromatography

A simple and accurate method to determine pitavastatin calcium (PIT) and ezetimibe (EZE), in binary mixture, was developed and validated using liquid chromatography (LC). The LC separation was achieved on a Phenomenex Luna C18 column (250 mm, 4.6mm i.d., 5μm), in the isocratic mode using 0.1 % orthophosphoric acid: acetonitrile: triethylamine (19.8: 80: 0.2, v/v/v), pH 3 ± 0.05, at a flow rate of 1.4 mL/min. The retention times were about 6.98 and 2.36 min for PIT and EZE, respectively. Quantification was achieved with Photodiode array (PDA) detector at 235 nm over the concentration range of 0.5-5 μg/mL for each, with mean recoveries of 99.35 ± 0.19 % and 99.51 ± 0.23 % for PIT and EZE, respectively. The method was validated, and was found to be simple, specific, accurate, precise and robust. The method was successfully applied for the determination of PIT and EZE in binary mixture without any interference from common excipients.