STABILITY INDICATING NEW RP-HPLC METHOD FOR THE DETERMINATION OF ROSUVASTATIN CALCIUM IN PURE AND TABLETS DOSAGE FORMS

A new, specific, precise, simple, and accurate RP-H PLC method is developed and validated for the deter mination of Rosuvastatin calcium (ROS-Ca) in pure and tablets dosage forms. The method is performed on the Agile nt Eclipse XDB C8 column (250 mm X 4.6 mm, 5μm particle size, using buffer solution of pH 4.5 containing 0.05M sodium dihydrogen phosphate: acetonitrile (50:50 v/v) as the mobile phase at a flow rate of 1.2 mL/min,injection volume 10 μL and UV detection at 245 nm. The total run time is 5.0 min. Linear relationship are obtained in the range 5-100 μg/mL and R t values of 3.684 min for ROS-Ca with correlation co efficient (r) = 0.9995, limit of detection 1.50 μgmL -1 and limit of quantitation is 4.56 μgmL-1 for ROS-Ca. The overall recovery is 100 ± 2 % ; the relative standard deviation for precision and intraday precision is less than 2.0 %. Also, the forced degradation studies as acidity, alkalinity, oxidation, heat and photo degradation are performed according to ICH guidelines. The method is validated according to ICH guidelines and USP requirements for new methods, which include accuracy, precision, specificity, LOD, LOQ, robustness, ruggedness, linearity and range. Hence this RP-HPLC method is suitable for quality control of raw materials and finished products.