SIMULTANEOUS RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF FENOFIBRATE AND ROSUVASTATIN CALCIUM IN BULK AND TABLET DOSAGE FORM

An isocratic reversed-phase liquid chromatograpic assay method was developed for the quantitative determination of fenofibrate and rosuvastatin calcium in bulk and tablet dosage form. A Lichrosphere Select-B C8 (250x4.6mm & 5.0μm) column with a mobile phase containing Solution A (Milli-Q water has pH3.0 made by orthophosphoric acid): Methanol (20:80). The flow rate was 1.0 mL min−1: 1.5 ml/min and the detection of fenofibrate and rosuvastatin calcium was carried out on absorbance detector at 254nm.The retention times was 12 min (rosuvastatin- 3.40, fenofibrate-7.75). A linear response r2 > 1.0 for fenofibrate in the range of 40- 300μg/ml and r2 > 0.9997 in the range of 2.8-21μg/ml for rosuvastatin calcium was observed. The proposed method was validated with respect to system suitability, specificity and selectivity, stability of analytical solutions linearity, accuracy, precision, and robustness. The method was successfully applied to the estimation of fenofibrate and rosuvastatin calcium in bulk and tablet dosage form. Keywords: RP-HPLC, fenofibrate, rosuvastatin calcium, Validation