摘要
目的:建立一种用手性固定相直接分离匹伐他汀钙对映体的方法并测定异构体的限量。方法:柱温25℃用α-酸性糖蛋白柱(150 mm×4.0mm,5μm),以0.03 mol·L^(-1)磷酸氢二钠溶液(用磷酸调 pH 值至6.5)-乙腈(90:10)为流动相,流速为1.0 mL·min^(-1),检测波长为245 nm。结果:α-酸性糖蛋白柱对匹伐他汀钙手性异构体有良好拆分能力,匹伐他汀钙及其异构体的分离度符合要求。结论:该方法操作简便,可用于匹伐他汀钙原料中异构体的限度控制。
Objective：To establish an HPLC method for the and its enantiomer with a chiral stationary phase. Methods：α- separation and determination of pitavastatin calcium -acid glycoprotein column was used as chiral column （ 150 mm×4.0mm,5μm） at 25 ℃ with 0. 03 mol · L^-1 sodium dihdrogenphosphate buffer - acetontrile （90： 10） as the mobile phase. The flow rate was 1.0 mL ·min^-1 and the detection wavelength was 245 nm. Results ：Pitavatatin Calcium and its enantiomer were separated well on the α - acid glycoprotein column and the resolution was consistent with the requirements. Conclusion：The method is suitable for the separation of pitavastatin calcium and its enantiomer, and is valuable for the limitation control of enantiomer of pitavastatin calcium.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2008年第8期1333-1335,共3页
Chinese Journal of Pharmaceutical Analysis
