盐酸左氧氟沙星注射剂异构体的测定  

STUDY ON THE ENANTIOMERIC SEPARATION OF LEVOFLEXACIN HYDROCHLORIDE INJECTION BY HPLC

作　　者：闫小燕[1] 谷大建 胡欣[1] 曹国颖[1] 何笑蓉[1] 宋友华[1] 

机构地区：[1]卫生部北京医院药剂科,北京100730 [2]济南市千佛山医院,山东济南250000

出　　处：《华西药学杂志》2000年第4期287-288,共2页West China Journal of Pharmaceutical Sciences

摘　　要：目的 :对盐酸左氧氟沙星注射剂中右旋体进行手性分离。方法 :采用手性流动相HPLC法 ,用ODS柱 ,检测波长 30 0nm ,流动相为甲醇∶手性溶液Ⅱ (1 5∶85 ,pH3 .0 )。 结果 :右旋体最低检测限 5ng,制剂辅料无干扰 ,重现性好。结论OBJECTIVE:Study for the chiral separation of the R oflexacin(R OFLX) in levoflexacin(L OFLX) injection.METHODS:the R OFXL was determined by HPLC with a chiral mobile phase additive.LC 18 column was used.the mobile phase consisted of methanol chiral liquid Ⅱ(15∶85,pH3.0).the UV wavelength was 300 nm.RESULTS:The detection limit was 5 ng for R OFLX.The relative standard deviation was not more than 0.51%.CONCLUSION:The method can be used for determination of enantiomeric purity for L OFLX pharmaceutical formulation.

关 键 词：左氧氟沙星 异构体 手性分离 注射剂 

分 类 号：R978.19[医药卫生—药品] R927.1[医药卫生—药学]