Development and Validation of RP-HPLC Method for the Estimation of Rosuvastatin Calcium and Niacin in Combined Tablet Dosage Form
A simple, specific, accurate and precise reverse phase high performance liquid chromatographic method was developed and validated for the estimation of Rosuvastatin and Niacin individually and combined tablet dosage form. An Inertsil ODS C-18, 5μm column having 15cm x 4.6mm internal diameter in isocratic mode with mobile phase containing potassium (dihydrogen) orthophosphate buffer: acetonitrile (50:50v/v) was used. The flow rate was 1.0 ml/min and effluents were monitored at 254 nm. The retention time for Rosuvastatin and Niacin was 1.58 and 4.84-5.5 min. The method was validated for linearity, accuracy, precision, specificity, limit of detection, limit of quantification and robustness. Limit of detection and limit of quantification were found in ng and recovery of Rosuvastatin and Niacin from tablet formulation was found 98-105 %. The accuracy of the method was checked by recovery experiment performed at three different levels i.e., 50%, 100% and 150%.The % recovery was found to be 98-105% for Rosuvastatin and niacin respectively. The low values of % R.S.D are indicative of the accuracy and reproducibility of the method. The % R.S.D value less than 2 indicate that the method is precise. The proposed method was successfully applied for the quantitative determination of Rosuvastatin and Niacin in tablet formulation.