建立了高效液相色谱法测定瑞舒伐他汀钙(1)原料药中的有关物质,采用Waters C_(18)色谱柱,以水(用冰乙酸调至pH 3.5)∶甲醇∶乙腈(54∶18∶28)为流动相,检测波长242 nm。方法学验证结果显示,1中各有关物质分离完全,本法专属性强、灵敏度高、耐用性好,结果准确可靠。1中的有关物质(2~10)分别在0.20~10、0.79~20、0.83~15、0.29~10、0.60~10、0.58~10、0.66~10、0.64~30和0.53~10μg/ml范围内线性关系良好,平均回收率为98%~102%,RSD均小于5%。 A HPLC method was developed for the determination of related substances in rosuvastatin calcium (1) API using Waters C 18 column with water (adjusted to pH 3.5 with glacial acetic acid): methanol: acetonitrile (54: 18:28) as the mobile phase, detection wavelength 242 nm. Methodological validation results show that 1 of the relevant substances completely separated, the law of specificity, high sensitivity, durability, the results are accurate and reliable. 1 in the range of 0.20-10.0.79-20.0.83-15.0.29-10.0.60-10.0.58-10.0.66-10.0.64-30 and 0.53-10 μg / ml, respectively Within the linear relationship, the average recovery was 98% to 102%, RSD were less than 5%.