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D. Bheemudu* and Dr. B. Raja


An accurate, sensitive and precise RP-HPLC method has been developed and validated for the simultaneous estimation of Rosuvastatin Calcium (ROS) and Fenofibrate (FEN) from bulk and Pharmaceutical Dosage form. The separation was achieved by Zorbax Eclipse plus C18 column (100mm X 4.6mm, 3.5μm) in isocratic mode, with mobile phase comprises of Acetonitrile: Water in proportion of 90:10v/v, pH 3 of the water was adjusted with Ortho Phosphoric Acid. The flow rate of mobile phase was 0.6 ml/min and the detection wavelength was 243nm. The retention time of Rosuvastatin calcium and Fenofibrate were 1.93min and 4.35min respectively. The calibration curve range was 2-16μg/ml for ROS and 14-112μg/ml for FEN. The regression data shows good linear relationship with 0.9974 for ROS and 0.9954 for FEN. The method was validated in accordance with the requirements of ICH guidelines. Moreover, the proposed analytical method was applied to monitor the formulation commercially available.

Keywords: Rosuvastatin Calcium (ROS) and Fenofibrate (FEN), Validation, RP-HPLC.

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