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Title : DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ROSUVASTATIN AND FENOFIBRATE IN BULK AND TABLET DOSAGE FORM
Authors : *S. Thukabai, V. Uma Maheshwara Rao and Muhammad Rafi Shaik
Abstract : A new precise, accurate, reliable validated method for the determination of Rosuvastatin and Fenofibrate has been developed by using reverse phase high performance liquid chromatography (RP-HPLC) in pharmaceutical dosage form. Chromatographic separation was carried out by using mobile phase 0.01M Potassium dihydrogen phosphate: methanol (55:45v/v, PH-2.6 adjusted with Orthophosphoric acid) on Agilent XDB C18 (150 x 4.6 mm, 5) at a flow rate 1ml/min with UV detection at 220nm.The retention times for Rosuvastatin and Fenofibrate were 2.36 and 5.80 min respectively and both drugs showed good linearity in the range of 5-20 µg/ml and 80-320 µg/ml. The proposed method has been successfully applied to pharmaceutical formulation and was validated according to ICH guidelines and method showed good precision with percentage relative standard deviation less than 2%. The percentage recovery for Rosuvastatin and Fenofibrate was found between 99.06-100.94% and 99.12-100.95% respectively indicating the proposed method was accurate and precise.

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