Abstract

An isocratic Simultaneous estimation by RP-HPLC Method was developed and validated for the quantification of ROSUVASTATIN CALCIUM and EZETIMIBE in tablet dosage form. Quantification was achieved by using a reversed-phase C18 column (Phenomenax C18 Column , 5μ, 250 mm × 4.6 mm) at ambient temperature with mobile phase consisting of 30mM Ammonium acetate buffer(pH:3.6) : Acetonitrile (40:60). The flow rate was 1.0 ml/min. Measurements were made at a wavelength of 227nm. The average retention time for ROSUVASTATIN CALCIUM and EZETIMIBE were found to be 3.09 min and 5.13. The proposed method was validated for selectivity, precision, linearity and accuracy. The assay methods were found to be linear from 60-140μg/ml for ROSUVASTATIN CALCIUM and 60-140μg/ml for EZETIMIBE. All validation parameters were within the acceptable range. The developed method was successfully applied to estimate the amount of ROSUVASTATIN CALCIUM and EZETIMIBE in tablet dosage form.