New RP-HPLC Method Development and Validation for the Estimation of Rosuvastatin Calcium in Bulk Drugs and Formulations

A simple, specific, accurate, and precise reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the estimation of Rosuvastatin calcium in pharmaceutical dosage forms. The chromatographic separation was done on Agilent zorbax reversed phase C18 (150 mm x 4.6 mm, 5 µm) column in isocratic mode, with mobile phase containing HPLC grade methanol:orthophaspaharic acid at pH 3.1 (35:65, v/v) was used. The flow rate was 1 ml / min and effluents were monitored at 282 nm. Chromatogram showed a main peak of Rosuvastatin calcium at retention time was 1.323 min. Beer's law was obeyed in the concentration range of 0.5-16 ìg/ml with correlation coefficient 0.9997. The method was validated for linearity, accuracy, precision, limit of detection, limit of quantitation, robustness and ruggedness. The limit of detection and limit of quantitation for estimation of Rosuvastatin calcium was found to be 0.056 µg / ml and 0.133 µg / ml, respectively. Recovery of Rosuvastatin calcium was founds in the range of 98.6-101.2%. Proposed method was successfully applied for the quantitative determination of Rosuvastatin calcium in pharmaceutical dosage forms.