A new, specific, precise, simple, and accurate RP-HPLC method is developed and validated for the determination of Rosuvastatin calcium (ROS-Ca) in pure and tablets dosage forms. The method is performed on the Agilent 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 Rt values of 3.684 min for ROS-Ca with correlation coefficient (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.
Key words: Rosuvastatin Calcium; Stability; Assay; tablets dosage form; ICH; USP; HPLC