VALIDATED RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF ROSUVASTATIN CALCIUM AND EZETIMIBE IN PHARMACEUTICAL DOSAGE FORM
Keywords:
Rosuvastatin Calcium, Ezetimibe, Method development, ValidationAbstract
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.
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References
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