摘要
目的：建立高效液相色谱法测定利伐沙班中对映异构体含量。方法：色谱柱为 Chiralpak IA（250 mm ×4.6 mm,5μm）,流动相为100%甲醇,流速为1.0 ml·min^-1,检测波长为250 nm,柱温为40℃。结果：利伐沙班与其对映异构体之间的分离度大于2.0,两者在0.5~1000.00μg·ml^-1范围内呈良好的线性关系,r均为0.9999,对映异构体检测限为0.17 ng,平均加样回收率为102.9%,RSD为1.54%（n=6）。结论：该方法准确、快速,可用于利伐沙班中对映异构体的含量测定。
Objective：To establish a method for the determination of enantiomer in rivaroxaban by HPLC. Methods：A Chiralpak IA column （250 mm × 4. 6 mm, 5 μm） was used with the mobile phase of 100% methanol. The flow rate was 1. 0 ml·min-1 . The detection wavelength was set at 250 nm and the column temperature was 40℃. Results：The resolution of rivaroxaban and the enanti-omer was above 2. 0. The linear range of them was 0. 5-1 000. 00 μg·ml^-1（r=0. 999 9）. The detection limit of the enantiomer was 0. 17ng and the average recovery was 102. 9% with RSD of 1. 54%（n=6）. Conclusion：The method is accurate and rapid, and suit-able for the determination of the enantiomer in rivaroxaban.
出处
《中国药师》
CAS
2014年第10期1629-1631,共3页
China Pharmacist
基金
科技部"十二五""重大新药创制"专项课题(编号:2013ZX09402103)
