A new validated RP-HPLC method for determination of Rosuvastatin calcium in bulk and pharmaceutical dosage form

摘要

A simple, rapid, and precise RP-HPLC method for analysis of Rosuvastatin calcium in bulk and its pharmaceutical formulations has been developed and validated. The separation was achieved on Luna C18, 5μm 4.6 mm×250 mm column, using mobile phase composition of buffer (pH 4.5): Acetonitrile: methanol (45:25:35), at a flow rate of 1.0 ml/min at a detection wavelength of 248 nm. Rosuvastatin is eluted at retention time of 9.9 min. The method was validated for accuracy, precision, linearity, specificity and sensitivity in accordance with ICH guidelines. Validation revealed the method is specific, rapid, accurate, precise, reliable, and reproducible. Calibration plots were linear over the concentration ranges 25-75 μg mL−1. Limits of detection and limits of quantification were 3.5μg mL−1 and 10.5μg mL−1, respectively for both the drugs. The high recovery and low coefficients of variation confirm the suitability of the method for analysis of the rosuvastatin in formulations.