毛细管电泳法分析手性药物度洛西汀

Analysis of chirai drug duloxetine by capillary zone electrophoresis

目的:采用毛细管区带电泳法分析手性药物度洛西汀及其 R-对映体。方法:以羟丙基-β-环糊精(HP-β-CD)为手性选择剂,考察了背景电解质中 Tris 缓冲液的 pH 和浓度、HP-β-CD 浓度、有机改性剂甲醇含量及分离电压对手性分离的影响。确定电泳条件为:55 mmol·L^(-1)Tris 缓冲液(pH 1.8,含40 mmol·L^(-1)HP-β-CD)-甲醇(80:20),分离电压20 kV,检测波长214 nm。结果:度洛西汀与其 R-对映体的分离度为1.66,度洛西汀在0.05～0.3 mg·mL^(-1)浓度范围内线性关系良好,而且能同时分离度洛西汀的合成中间体及其对映异构体。结论:此方法能用于度洛西汀的分析测定及其合成中间体的纯度控制。

Objective： Duloxetine and its R - enantiomer were separated by capillary zone electrophoresis. Method： Hydroxypropanyl- β- cyclodextrin（ HP-β- CD）was used as chiral selector. The influences of the concentration and pH of Tris buffer solution, HP - β - CD concentration, methanol content and separation voltage were investigated. The best separation was achieved with background electrolyte of 55 mmol · L^-1 Tris buffer（ pH 1.8）containing 40 mmol · L^-1HP-β -CD -methanol（80： 20）,at an applied voltage of 20 kV,and UV detection at 214 nm. Results：The resolution of duloxetine and its R - enantiomer was 1.66, the linear concentration range of duloxetine was 0. 05 - 0. 3 mg · mL^-1. Duloxetine,its R - enantiomer and the related intermediates were simultaneously separated. Conclusion：This method is applyable to the purity control of duloxetine and its intermediate.