Application of UV-Spectrophotometry and RP-HPLC for Simultaneous Determination of Atorvastatin Calcium and Ezetimibe in Pharmaceutical Dosage Form

Abstract

Two methods are described for the simultaneous determination of Atorvastatin calcium and Ezetimibe in binary mixture. The first method was based on UV-spectrophotometric determination of two drugs, using simultaneous equation method. It involves absorbance measurement at 232.5 nm (λmax of Ezetimibe) and 246.0 nm (λmax of Atorvastatin calcium) in methanol; linearity was obtained in the range of 5 – 25 μg.mL-1 for both the drugs. The second method was based on HPLC separation of the two drugs in reverse phase mode using Luna C18 column. Linearity was obtained in the concentration range of 8-22 μg.mL-1 for both the drugs. Both these methods have been successively applied to pharmaceutical formulation and were validated according to ICH guidelines.