METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF ROSUVASTATIN CALCIUM AND EZETIMIBE IN PHARMACEUTICAL DOSAGE FORM BY RP-HPLC

Abstract

A simple, precise and efficient high performance liquid chromatographic method was developed for simultaneous determination of Rosuvastatin calcium and Ezetimibe in tablets. A symmetry C18 column 75×4.6mm i.d. 3.5µ in isocratic mode with mobile phase containing Acetonitrile: methanol: buffer (0.01M sod.dihydrogen phosphate) (30:20:50 v/v) pH adjusted to 3.0 using ortho phosphoric acid (v/v) .The flow rate was 1.0 ml/min and effluent was monitored at 263 nm. The retention time and linearity range for Rosuvastatin calcium and Ezetimibe were (3.88, 8.16 min) and (10-60, 10-60 μg/ml), respectively. The validation of the proposed method was carried out for its specificity, linearity, accuracy, precision, limit of detection and quantification for both Rosuvastatin calcium and Ezetimibe. The developed method can be used for simultaneous determination of Rosuvastatin calcium and Ezetimibe in tablet dosage form.