手性配位交换色谱法拆分普卢利沙星对映体  

Enantiomeric Separation of Prulifloxacin by Chiral Ligand-Exchange Chromatography

作　　者：陈希 鄢雷娜 刘绪平 肖钦钦 段和祥 陈伟康 CHEN Xi;YAN Leina;LIU Xuping;XIAO Qinqin;DUAN Hexiang;CHEN Weikang(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,江西南昌330029

出　　处：《分析科学学报》2022年第1期99-102,共4页Journal of Analytical Science

基　　金：江西省药品监督管理局科研项目(No.2019JS15)。

摘　　要：以L-异亮氨酸和CuSO_(4)作为手性流动相添加剂,采用手性配位交换色谱法拆分普卢利沙星对映体。考察了添加剂的种类、浓度、比例以及流动相pH等因素对拆分的影响。优化的色谱条件为:C_(18)色谱柱,流动相为8 mmol/L L-异亮氨酸和4 mmol/L CuSO_(4)溶液(pH=3.5)-甲醇(68∶32,V/V),流速为1.0 mL/min,检测波长为276 nm。结果表明:在上述条件下,普卢利沙星对映体的分离度(R_(S))大于3.6。该方法可用于普卢利沙星对映体的拆分及普卢利沙星的质量控制。The enantiomers of plurixacin were separated by chiral ligand-exchange chromatography using L-isoleucine and copper sulfate as chiral mobile phase additives.The influence factors such as the type of chiral additive,concentration,ratio of chiral additive,pH of mobile phase were investigated.The optimized chromatographic condition was obtained when the mobile phase consisted of 8 mmol/L L-isoleucine and 4 mmol/L copper sulfate(pH=3.5)-methanol(68∶32,V/V)at the flow rate of 1.0 mL/min with C_(18) column.The detection wavelength was 276 nm.As a result,the enantiomeric resolution of prulifloxacin was greater than 3.6.This method can be used for the separation and quality control of the enantiomers of prulifloxacin.

关 键 词：高效液相色谱法 手性流动相添加剂 普卢利沙星对映体 手性拆分 

分 类 号：O657.72[理学—分析化学]