Abstract

A simple, rapid, economic, sensitive and precise RP-HPLC method has been developed for the simultaneous determination of Rosuvastatin calcium and Fenofibrate in bulk and pharmaceutical dosage form. The method was carried out using Greece C18 (4.6ID × 250mm; 5μm) column and mobile phase comprised of methanol and water in proportion of ratio 90:10 v/v and degassed under ultrasonication. The flow rate was 1.0 mL/min and detection was carried out at 254 nm. The retention time of ROS and FEN were found to be 3.316 min and 4.413 min respectively. The described method shows excellent Linearity of ROS and FEN were in the range of 10 to 50 μg/mL and 67 to 335 μg/mL respectively. The % recoveries of ROS and FEN were found to be in between 97.94% to 99.81% for ROS and 97.18% to 98.49% for FEN respectively. The method was also applied for the determination of ROS & FEN in the presence of their degradation products formed under variety of stress conditions. Degradation products produced as a result of stress studies did not interfere with the detection of ROS and FEN. The correlation coefficient for both drug was 0.999 and 0.9981 respectively. The limit of detection for ROS and FEN were 0.0621 and 0.980 μg/mL respectively. The limit of quantification was 0.188 and 2.970 μg/mL respectively. The robustness study and percentage of assay of the formulation were found within limit as per ICH guidelines.