RP-HPLC Method for Simultaneous Estimation of Atorvastatin Calcium Ezetimibe in Pharmaceutical Formulation

A simple, selective, rapid and precise reverse phase HPLC method has been developed for the simultaneous estimation of Atorvastatin calcium and Ezetimibe in pharmaceutical dosage form. A Hypersil BDS (250 mm×4.6 mm i.d 5μ) column was used for Separation. The mobile phase was Acetonitrile:water:Methanol (350:550:100, v/v) and adjust Ph to 4.0 with Orthophosphoric acid. Flow rate 2.0 ml/min with detection at 250 nm. The retention time of Atorvastatin calcium and Ezetimibe was 21.712 and 10.414 min. respectively. The developed method was validated in terms of accuracy, precision, Linearity, specificity and forced degradation, robustness, solution stability, system suitability, limit of detection. The proposed method can be used for these drugs in combined dosage forms. The proposed RP-HPLC Method for the simultaneous estimation of Atorvastatin calcium and Ezetimibe in combined dosage form is accurate, precise, linear, rugged, robust, simple, rapid and selective. It can be easily adopted for routine quality control (QC) analysis of raw materials, formulation studies. pH of the mobile phase is 4, which is good to increase the shelf life of the column.