SIMULTANEOUS ESTIMATION OF ROSUVASTATIN CALCIUM AND EZETIMIBE AS BULK DRUG AND IN TABLET DOSAGE FORM BY RP-HPLC METHOD

A simple, rapid, specific and sensitive reverse phase high performance liquid chromatography was developed and validated for simultaneous estimation of Rosuvastatin calcium and Ezetimibe in combined tablet formulation. The separation was achieved by Thermo C18 column (4.6mm x 250 mm) with a mobile phase consisting of Acetonitrile: Water (80: 20 v/v) at a flow rate of 1.0 mL min-1 . Detection wavelength was 241 nm. Retention times were found to be 1.758 min and 3.133 min for Rosuvastatin calcium and Ezetimibe, respectively. The developed method was validated interms of linearity, precision, accuracy, limit of detection, limit of quantitation and robustness. The method was found to be linear in the concentration range 5-30 μg mL-1 for both the drugs. The method was applied successfully for the analysis of drugs in combined tablet dosage form. The mean % recovery was found to be 101.16 and 100.11 for Rosuvastatin calcium and Ezetimibe, respectively. The developed method can be used for the simultaneous quantification of these drugs in the dosage form, bulk drug as well as for routine analysis in quality control laboratories. Keywords: Rosuvastatin, Ezetimibe, RP-HPLC; Method validation, ICH Guidelines