HPLC法测定瑞舒伐他汀钙原料药的有关物质

Determination of Rosuvastatin Calcium related substances by HPLC

目的:采用HPLC法测定瑞舒伐他汀钙的有关物质。方法:采用Waters Symmetry C8(4.6 mm×150 mm,5μm)色谱柱;流动相A为水∶甲醇和乙腈混合液(1∶9)=80∶20,流动相B为甲醇,梯度洗脱;流速:1.0 m L/min;检测波长242 nm,柱温为30℃。结果:瑞舒伐他汀钙在水平2%至水平120%范围内线性关系良好;专属性、精密度、稳定性符合要求。结论:本法简便、准确,适用于瑞舒伐他汀钙有关物质测定。

Objective： To establish an HPLC method for assay test of Rosuvastatin Calcium. Methods： The analytical column was Symmetry C8（4.6 mm×150 mm, 5 μm） column. The mobile phase A was water-methanol-acetonitrile（1∶8∶1）, mobile phase B was methnol, gradient elution at a flow rate of 1.0 m L/min. The wavelength of UV detector was 242 nm and column temperature was 30 ℃. Results： The linear range of Rosuvastatin Calcium was 2 % to 120 %. Specificity, precision and stability meet the requirements. Conclusion： The method is simple, accurate and suitable for related substances test of Rosuvastatin Calcium.