Novel Isocratic RP-HPLC Method Development and Validation of Rosuvastatin and Fenofibrate in Tablets

A novel simple selective, precise, and accurate reverse phase-high performance liquid chromatography (RP-HPLC) isocratic method was developed for the simultaneous estimation of rosuvastatin and fenofibrate in the combined formulation. The drugs rosuvastatin calcium and fenofibrate were separated in presence of fenofibrate related compound A and fenofibrate related compound B. The drugs and related compounds were separated on Kromasil C18 (250 × 4.6, 5 μ) with a reverse phase isocratic elution. 0.01M potassium dihydrogen phosphate adjusted pH 3.0 with dilute phosphoric acid used as a buffer and acetonitrile used as a solvent in the mobile phase with a ratio of 30:70, respectively. The flow rate was 1 mL/min. 242 nm was the detection wavelength. The retention times were about 3.1 minutes for rosuvastatin calcium, 4.7 minutes for fenofibrate related compound A, 5.6 minutes for fenofibrate related compound B, and 21.6 minutes for fenofibrate. The linearity ranges for rosuvastatin calcium and fenofibrate were 50 to 150 and 800 to 2,400 mcg/mL, respectively, with a correlation coefficient of 0.999 for both. The proposed method validated statistically with respect to system suitability, specificity, linearity, and range, precision, accuracy, robustness, and ruggedness. The method was accurate, linear, precise, specific, selective, and rapid suitable for the quantitative estimation of rosuvastatin and fenofibrate in tablets.