Ali, H; Zafar, F; Shah, SN; Mallick, N; Naveed, S; Naqvi, GR; Hasnain, H; Maroof, K; Qureshi, S
Rosuvastatin as a HMG-CoA reductase inhibitor exhibits several distinctive pharmacological and pharmacokinetic characteristics. Various clinical trials, post marketing surveillance and cardiovascular outcome investigations have shown the valuable and useful effects of this compound. Literature related to rosuvastatin comprised a small number of methods based on UV-spectroscopic or chromatographic techniques. In current investigation, a RP-HPLC method was designed and validated for the evaluation of rosuvastatin in bulk and finished products. In this method mobile phase was acetonitrile: dilute orthophosphoric acid (OPA) prepared by adding 1 mL in 1 L H2O in 65:35 ratio. Final pH of the solution was 3.2. System integration was performed with data handling system CSW 1.7, using column Li-Chrospher 250 x 4.6 mm C-18 (5 mu m). Mobile phase was introduced into the system with flow rate of 1 mL/min and quantification was done at 244 nm. Total run time was 6 min. Parameters of validation were evaluated in terms of linearity, precision, accuracy, range, specificity, sensitivity and robustness. Presented method has illustrated acceptable linearity in the range of 1.25-60 mu g/mL. Accuracy of the method was estimated by spanning the sample between 50-100% concentration ranges and results were observed in acceptable values (% RSD < 2). The intraday precision for concentrations of 5, 10 and 15 mu g/mL, were found in order of 99.987, 99.784, and 99. 562%, respectively, while for interday (day 1, 2 and 3), these values were found to be 99.995, 99.234, and 98.976 %, respectively. The presented method was precise, specific, sensitive (LOD: 1.25 mu g/mL), rapid (run time = 6 min) and economical with satisfactory resolution properties. Hence this method can be applied successfully for the determination of rosuvastatin in pharmaceutical product.