HPLC测定瑞舒伐他汀钙片中的有关物质

Determination of the Related Substances of Rosuvastatin Calcium Tablets by HPLC

目的建立瑞舒伐他汀钙片有关物质的高效液相色谱测定方法。方法采用Diamonsil C18（4.6 mm×250 mm,5μm）色谱柱,以乙腈-0.02 mol·L^-1醋酸铵缓冲液（冰醋酸调节p H至4.0±0.05）（50∶50）为流动相,流速为1.0 m L·min^-1,检测波长为242 nm。结果瑞舒伐他汀在0.05-0.5 mg·m L^-1内线性关系良好（r=1.000 0）,有关物质与主药分离良好,瑞舒伐他汀、非对映体、氧化降解产物、光降解产物和内酯的检出限分别为4,20,300,200和15 ng。结论该方法操作简单,重复性好,专属性强,可用于瑞舒伐他汀的有关物质检查。

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 p H to 4.0±0.05 with glacial acetic acid） at a flow rate of 1.0 m L·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·m L^-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.