VALIDATED RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF ROSUVASTATIN CALCIUM AND EZETIMIBE IN PHARMACEUTICAL DOSAGE FORM
Journal Title: International Journal of Pharmacy and Pharmaceutical Sciences - Year 2015, Vol 7, Issue 4
Abstract
Objective: To develop and validate a rapid, sensitive and specific reverse phase high performance liquid chromatography (RP-HPLC) method for simultaneous determination of Rosuvastatin Calcium and Ezetimibe in a combined dosage form.Methods: The chromatographic separation of the two drugs were achieved using Enable C18G (5 μm, 250 mm x 4.6 mm i. d. column). The drugs were separated in isocratic elution mode with a mobile phase consists of Acetonitrile-Water (75:25, v/v) at a flow rate of 0.6 ml/min and a detection wavelength of 252 nm using a UV detector.Results: The linearity and range for both Rosuvastatin Calcium and Ezetimibe were 5-40 µg/ml (R2= 0.9995) and 5-40 µg/ml (R2= 0.9992), respectively. Accuracy of the method was determined through recovery studies by adding known quantities of standard drug to the preanalyzed test solution and was found to be 99.6-100.3 % and 99.5-99.9% for Rosuvastatin Calcium and Ezetimibe respectively. The % RSD values for both interday and intraday precision were found to be<2%.Conclusion: A rapid, sensitive and specific RP-HPLC method was developed and validated for simultaneous determination of Rosuvastatin Calcium and Ezetimibe in a combined dosage form and hence, it can be used in the quality control analysis of an active pharmaceutical ingredient and pharmaceutical dosage form.Â
Authors and Affiliations
Swathi Sri D, Hemant Kumar T, Vara Prasada Rao K, Srinivasa Rao Y
Keywords
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