Analytical method development and validation for the simultaneous estimation of Rosuvastatin and Finofibate in tablet dosage form by reverse phase high performance liquid chromatography
Journal Title: Indian Journal of Research in Pharmacy and Biotechnology - Year 2013, Vol 1, Issue 6
Abstract
A new, simple, precise, accurate and reproducible RP-HPLC method for Simultaneous estimation of Rosuvastatin (ROS) and Fenofibrate (FEN) in bulk and pharmaceutical formulations was developed. Separation of ROS and FEN was successfully achieved on a Hypersil C18 (4.6 x 250mm, 6.5 m, Make: Waters) or equivalent in an isocratic mode utilizing OPA buffer (pH 3.0): Methanol (65:35%v/v) at a flow rate of 1.2 mL/min and eluate was monitored at 238 nm, with a retention time of 1.950 and 3.858 minutes for ROS and FEN. The method was validated and the response was found to be linear in the drug concentration range of 50 µg/mL to 150 µg/mL for ROS and 50 µg/mL to 150 µg/mL for FEN. The values of the slope, intercept and the correlation coefficient were found to be 2 2 507, 7467 and 0.999 for ROS and 21157, 16980 and 0.999 for FEN respectively. The LOD and LOQ for Rosuvastatine were found to be 0.0053, 0.017 respectivly. The LOD and LOQ for Fenofibrate were found to be 0.00019, 0.00063 respectively. This method was found to be good percentage recovery for Rosuvastatine and Fenofibrate were found to be 99.00 and 99.00 respectively indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard with the sample so, the method specifically determines the analyte in the sample without interference from excipients of tablet dosage forms. The method was extensively validated according to ICH guidelines for Linearity, Range, Accuacy, Precesion, Specificity and Robustness.
Authors and Affiliations
M. Sumalatha, K. Haritha Pavani
Keywords
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