手性固定相HPLC法直接拆分奈他地尔对映体  

Directly enantioseparation of netarsudil enantiomers by high performance liquid chromatography on chiral stationary phase

作　　者：周鑫鑫[1] 周宁[1] 刘长春[1] ZHOU Xin-xin , ZHOU Ning and LIU Chang-chun(Jiang Su Food ＆ Pharmaceutical Science College, Huai＇an 223003)

机构地区：[1]江苏食品药品职业技术学院,淮安223003

出　　处：《分析试验室》2018年第4期471-474,共4页Chinese Journal of Analysis Laboratory

摘　　要：以纤维素衍生物为手性固定相,建立药物奈他地尔的HPLC手性分析方法。以正己烷与乙醇或异丙醇为流动相,在Chiralpak AD-H手性固定相上对奈他地尔对映体进行了拆分,并考察了流动相组成、柱温和流速对该对映体分离的影响,获得较优分析条件,分析时间在15 min内,分离度大于1.7。结果表明,奈他地尔对映体在正己烷-异丙醇-二乙胺(80:20:0.1,V:V:V)为流动相、流速为1.0 m L/min、柱温为30℃时,分离效果最佳。本方法操作简单、重现性好,可用于奈他地尔对映体的质量控制。A method for separating the racemate and determining the enantiomeric purity of netarsudil was established by cellulose chiral stationary phase. Chromatographic model was employed for enantioseparation of netarsudil on the Chiralpak AD-H chiral column in hexane/alcohol（ ethanol or isopropyl alcohol） mobile phase. The effects of chromatography conditions,such as mobile phase,temperature and flow rate to chiral recognition,were investigated. A better condition of analysis was obtained within a short run time of less 15 min. The resolution was more than 1. 7. The results indicated that a good separation was obtained at 30℃by using hexane-isopropyl alcohol-ethylenediamine（ 80： 20： 0. 1,V/V/V） as the mobile phase with a flow rate of 1. 0 m L/min. The presented study provided a simple and reproducible method for the enantiomeric quality control of netarsudil.

关 键 词：高效液相色谱法 手性固定相 奈他地尔 对映体拆分 

分 类 号：R917[医药卫生—药物分析学]