HPLC手性固定相法拆分阿普斯特对映体

目的：建立新的高效液相色谱手性固定相法分离阿普斯特（Apremilast）的一对对映体。考察流动相组成、添加剂种类以及柱温等对阿普斯特对映体分离的影响。方法：采用Chiralpak OJ-H（4.6mm×250mm，5μm）色谱柱；以正己烷-异丙醇（45∶55）为流动相；流速为1.0mL·min-1；检测波长：254nm。结果：阿普斯特的两个对映异构体能得到良好的分离。结论：本方法操作简便，快速，重复性良好，适合阿普斯特的对映体分离及光学纯度的测定。

High performance liquid chromatographic separation of Apremilast using chiral column

Objective :A new method for the separation of Apremilast enantiomers was developed using high performance liquid chromatography with a chiral column as the stationary phases. The composition of mobile phase, types of mobile phase additives and column temperature were optimized to get better resolution.Methods :A Chiralpak IA (4.6mm×250mm,5μm)column was used, and the mobile phase was composed of hexane-isopropanol (45∶55) with a flow rate of 1.0mL·min-1. The detection wavelength was set at 254nm. Results :Good baseline separation of Apremilast could be achieved under the optimized conditions. Conclusion:This method was simple, rapid, considerably reproducible and suitable for the enatiomers separation and the optical purity determination of Apremilast.