羟丙基-β-环糊精手性流动相添加剂法拆分那氟沙星对映体  

Separation of nadifloxacin enantiomers by HPLC using hydroxylpropyl-β-cylcodextrin as chiral mobile phase additive

作　　者：陈希 刘绪平 肖钦钦 段和祥 张文婷 鄢雷娜 CHEN Xi;LIU Xuping;XIAO Qinqin;DUAN Hexiang;ZHANG Wenting;YAN Leina(Jiangxi Institute for Drug Control,NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine,Jiangxi Province Engineering Research Center of Drug and Medical Device Quality,Nanchang 330029)

机构地区：[1]江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,南昌330029

出　　处：《分析试验室》2020年第12期1426-1429,共4页Chinese Journal of Analysis Laboratory

基　　金：江西省药品监督管理局科研项目(2019JS15)资助。

摘　　要：采用羟丙基-β-环糊精(HP-β-CD)作为手性流动相添加剂,建立反相色谱法分离那氟沙星对映体的方法。考察了缓冲盐浓度和p H、HP-β-CD浓度、乙腈比例等对映体分离的影响。采用Welch XB-C18色谱柱(4.6 mm×250 mm,5μm),优化流动相为0.05 mol/L KH2PO4溶液(含7.5 mmol/L的HP-β-CD,pH 6.9)-乙腈(V:V,83∶17),流速:1.0 mL/min,检测波长:290 nm。结果表明,那氟沙星对映体达到完全分离,分离度为2.1。该方法操作简单,比手性固定相法更经济实用,适用于那氟沙星对映体的拆分。Hydroxypropyl-β-cyclodextrin(HP-β-CD)was used as a chiral mobile phase additive to establish a method for separating enantiomers of nafloxacin by reversed-phase chromatography.The effects of buffer salt molar concentration,p H,HP-β-CD molar concentration,acetonitrile ratio and other factors on enantiomeric separation were investigated.A Welch XB-C18 column(4.6 mm×250 mm,5μm)was used,and the optimized mobile phase was 0.05 mol/L potassium dihydrogen phosphate solution(containing 7.5 mmol/L HP-β-CD,p H 6.9)-acetonitrile(V:V,83:17)at a flow rate of 1.0 m L/min,and detection wavelength of 290 nm.As a result,the enantiomers of nafloxacin were completely separated with a resolution of 2.1.This method is simple to operate,more economical and practical than the chiral stationary phase method,and is suitable for the resolution of the enantiomers of nafloxacin.

关 键 词：那氟沙星 对映体 拆分 羟丙基-Β-环糊精 

分 类 号：R917[医药卫生—药物分析学]