摘要
建立了测定药物尼拉帕尼对映体纯度的HPLC分析方法。以正己烷与乙醇或异丙醇为流动相,在Chiralpak AD-H手性固定相上对尼拉帕尼对映体进行了拆分,并考察了流动相组成、柱温和流速对该对映体分离的影响。尼拉帕尼对映体在正己烷-异丙醇-二乙胺(85:15:0.1,V/V/V)为流动相、流速为1.0 m L/min、检测波长260 nm、柱温为30℃时,分析时间在15 min内,分离度大于2。本方法操作简单、重现性好,可用于尼拉帕尼对映体的质量控制。
A method for determining the enantiomeric purity of niraparib was established by HPLC.Chromatographic model was employed for enantioseparation of niraparib 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 on chiral recognition,had been investigated.The results indicated that a good separation was obtained at 30℃ by using hexaneisopropyl alcohol-ethylenediamine(85: 15: 0.1,V/V/V) as the mobile phase,with a flow rate of1.0 m L/min and the detection wavelength of 238 nm.The analysis time was less than 15 min,and the resolution was more than 2.The presented study provided a simple and reproducible method for the enantiomeric quality control of niraparib.
作者
周鑫鑫
周宁
刘长春
ZHOU Xin-xin;ZHOU Ning;LIU Chang-chun(Jiang Su Food & Pharmaceutical Science College, Huaian, 22300)
出处
《分析试验室》
CAS
CSCD
北大核心
2018年第6期726-729,共4页
Chinese Journal of Analysis Laboratory
关键词
高效液相色谱法
手性固定相
尼拉帕尼
对映体拆分
High performance liquid chromatography
Chiral stationary phase
Niraparib
Enantioseparation