A simple, efficient and reproducible RP-HPLC method for the simultaneous estimation of ezetimibe and rosuvastatin in bulk and tablet dosage form has been developed and validated. The separation was carried out on ZORBAX SB C18 column (4.6 mm X 150mm, 3.5 �µm) column using potassium dihydrogen orthophosphate buffer (adjusted to pH2.5 with 0.1% OPA): methanol : acetonitrile in the ratio of 45:40:15 (v/v/v) as eluent. The flow rate was 1.5 ml/min and effluent was detected at 242 nm. The retention time of ezetimibe and rosuvastatin were 5.046 and 3.030 min. respectively. The linear dynamic range was 4-20 ppm for ezetimibe and 4-25 ppm for rosuvastatin respectively. Percentage recoveries for ezetimibe and rosuvastatin were 99.98% and 100.6% respectively. All the analytical validation parameters were determined and found in the limit as per ICH guidelines, which indicates the validity of the method. The developed method was also found to be precise and robust for the simultaneous determination of ezetimibe and rosuvastatin.
Loading....