超临界流体色谱法拆分萘普生对映体

Chiral Separation of Naproxen Enantiomers by Supercritical Fluid Chromatography

目的:建立拆分萘普生对映体的方法。方法:采用超临界流体色谱法。以萘普生对映体的分离时间、容量因子、分离因子、分离度为考察指标,优选手性色谱柱、流动相中极性添加剂种类及占比、背压和柱温的条件。结果:优选条件为手性色谱柱采用CHIRALPAK®AD-H,极性添加剂为异丙醇(占比为20%),背压170 bar,柱温20℃,检测波长283 nm。在此条件下萘普生对映体能够达到基线分离,分离度为4.31,分离因子为1.90,且精密度、稳定性和重复性试验中相关指标的RSD均≤2.65%(n=5)。结论:建立的拆分方法简单、重现性好、拆分效果好,可用于萘普生对映体的手性分离。

OBJECTIVE：To develop a method for the separation of naproxen enantiomers. METHODS：The supercritical fluid chromatography（SFC）method was adopted. The chiral column,type and proportion of polar additive in mobile phase,back pressure and column temperature were optimized using the separation time,capacity factor,separation factor and separation degree as index. RESULTS：The best condition was on the chiral column CHIRALPAK#174;AD-H,with polar additive of isopropanol（20%）,back pressure of 170 bar,column temperature of 20 ℃ and the detection wavelength of 283 nm. Under this condition,baseline separation of naproxen enantiomers can be achieved;separation degree was 4.31 and separation factor was 1.90;RSD of precision,stability and reproducibility tests were no more than 2.65%（n=5）. CONCLUSIONS：Established method is simple,reproducible and well-separated,and can be used for chiral separation of naproxen enantiomers.