HPLC法测定盐酸莫西沙星中R-异构体含量  

HPLC assay of R-isomer in moxifloxacin hydrochloride

作　　者：杨小明[1] 刘钦伟[1] 丁秀艳[1] 李语如[1] 

机构地区：[1]江苏恒瑞医药股份有限公司研究所,连云港222047

出　　处：《药物分析杂志》2012年第1期92-94,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立HPLC法对盐酸莫西沙星S-和R-异构体进行拆分并测定其中R-异构体含量。方法:采用AD-H手性柱(DAICEL CHIRALPAK,250 mm×4.6 mm,5μm),流动相为正己烷-异丙醇-二乙胺-乙酸(85∶15∶0.2∶0.1),流速1.0 mL.min-1,柱温35℃,检测波长293 nm;进样量10μL。结果:盐酸莫西沙星异构体之间的分离度为3.4,R-异构体的线性范围为0.54～5.40μg.mL-1(r=0.9995),检测限为1.1 ng,平均回收率(n=9)为99.2%。结论:该方法操作简便,结果准确,可用于盐酸莫西沙星中R-异构体含量测定。Objective： To establish an HPLC method for enantioseparation of S - and R - moxifloxacin hydrochloride and assay of the R - isomer. Methods： The separation was performed on an AD - H chiral column （ DAICEL CHIRALPAK, 250 mm ×4. 6 mm, 5 μm）. The mobile phase was n-hexane -iso-propylalcohol -diethylamine -acetic acid（85： 15：0. 2：0. 1） at the flow rate of 1.0 mL· min^-1 ; The column temperature was 35 ℃, and the detection wavelength was set at 293 nm; The injection volume was 10 μL. Results： The resolution of the isomer was 3.4, the linear range of the R - isomer was 0. 54 - 5.40 μg · mL^- 1 （ r = 0. 9995 ） , the detection limit was 1.1 ng and the average recovery（ n =9） was 99.2%. Conclusion： The method is simple and accurate, and can be used for assay of R - isomer in moxifloxacin hydrochloride.

关 键 词：高效液相色谱 手性柱 盐酸莫西沙星 异构体拆分 杂质分离 生产过程监测 

分 类 号：R917[医药卫生—药物分析学]