摘要
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%。
An HPLC method was established for the determination of the related substances in rosuvastatin calcium （1）. A Waters Symmetry C18 column was used, with the mobile phase of water （adjusted to pH 3.5 with acetic acid） ： methanol ： acetonitrile （54 ： 18 ： 28）, at the detection wavelength of 242 nm. The method validation results showed that 1 and its related substances 2--10 could be separated completely, and this method was specific, sensitive, accurate and reproducible. The calibration curves for 2--10 were linear in the ranges 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 p.g/ml, respectively. Their average recoveries were 98.3 %, 99.9%, 99.1%, 100.7%, 100.3%, 99.5%, 101.3%, 100.8% and 101.1%, respectively, with RSDs less than 5%.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2017年第8期1194-1198,共5页
Chinese Journal of Pharmaceuticals
