Development and Validation of Derivative Spectroscopic Method for the Simultaneous Estimation of Rosuvastatin Calcium and Fenofibrate in Tablet
A simple, novel, sensitive and precise validated spectrophotometric method was developed for simultaneous determination of Rosuvastatin calcium and Fenofibrate in synthetic mixture and its dosage form. Methanol was selected as a common solvent for estimation of Rosuvastatin calcium (ROS) and Fenofibrate (FEN) with λmax at 243 nm and 224 nm respectively in methanol. The linearity was obtained in the concentration ranges of 4-12 μg/ml for Rosuvastatin and 16-48 μg/ml for Fenofibrate. The Zero Crossing Point (ZCP) of Rosuvastatin was 224.11 nm and Fenofibrate was 243.29 nm. The correlation coefficient for the ROS was 0.9963and for FEN 0.9996. The % RSD for intraday precision was 0.76-1.05 % for ROS and 0.32-1.16 % for FEN. The interday precision was 0.76-1.82 % and 0.42-1.47 % for ROS and FEN respectively. The detection limit and quantification limit were found to be 1.96 and 5.96 μg/ml for Rosuvastatin and 0.76 and 2.32 μg/ml for Fenofibrate respectively. All the validation parameter was perform as per the International Conference on Harmonization (ICH) guidelines. The recovery study was carried out, result were 100.9-103.2% for ROS and 100.9-101.3% for FEN. No interference form the tablet excipients showed the applicability of method to the routine analysis of the pharmaceutical dosage form.