Determination of the Related Substances of Rosuvastatin Calcium Tablets by HPLC

OBJECTIVE To establish a method for determination of the related substances of rosuvastatin calcium tablets by HPLC. METHODS A Diamonsil C₁₈ column (4.6 mm×250 mm, 5 μm) was used. The mobile phase was acetonitrile-0.02 mol·L^-1 ammonium acetate (50∶50, adjust pH to 4.0±0.05 with glacial acetic acid) at a flow rate of 1.0 mL·min^-1, and the detection wavelength was 242 nm. RESULTS The resolutions of rosuvastatin and other related substances were good, and the linear range of rosuvastatin was 0.05-0.5 mg·mL^-1(r=1.000 0). The limit quantitation of rosuvastatin, diastereomer, oxidative breakdown product, photodegradation product and inner ester were 4, 20, 300, 200, 15 ng. CONCLUSION The method is convenient, accurate and exclusive for the determination of related substances of rosuvastatin.