高效液相色谱手性固定相法拆分尼拉帕尼对映体

Tioseparation of niraparib enantiomers by high performance liquid chromatography on chiral stationary phase

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.