盐酸舍曲林的手性分离与纯度检查  

Chiral separation and purity test of sertraline hydrochloride

作　　者：袁京群[1] 王华[1] 李士敏[1] 吴筱丹[1] 楼健[1] 

机构地区：[1]浙江大学农生环测试中心,杭州310058

出　　处：《药物分析杂志》2013年第9期1542-1545,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立手性分离盐酸舍曲林的毛细管区带电泳方法,并检查光学纯度。方法:采用未涂层石英毛细管(50 cm×50μm,有效长度40 cm),考察了手性选择剂的种类、浓度,缓冲液种类、pH、分离电压对手性拆分的影响,从而确定最佳分离条件。结果:盐酸舍曲林对映异构体的分离电泳条件为:以25 mmol·L-1磷酸-三乙醇胺(pH为2.50,内含3%β-环糊精硫酸钠盐)为运行缓冲液;检测波长为214 nm;工作电压为-20 kV,温度为25℃。结论:该毛细管电泳法能基线分离盐酸舍曲林的4个异构体;能有效检查盐酸舍曲林的光学纯度,该方法可用于该原料及其相关制剂的异构体杂质的质量控制和稳定性研究。Objective：To establish a cyclodextrin modified capillary zone electrophoretic method for the chiral sepa- ration of sertraline hydrochloride, and evaluate the optical purity using β - cyclodextrin sulfated sodium as the chiral selector. Methods： Fused - silica capillary 50 cm × 50 μm was adopted. The effects of cyclodextrin type, concen- tration of chiral selector, BGE composition, pH and running voltage were investigated. Results： Sertraline and oth- er three isomers were well separated with the running buffer consisting of 25 mmol . L-1 phosphate -triethano- lamine, 3% β-cyelodextrin sulfated sodium at pH 2.50. The running voltage was -20 kV, the temperature was 25 ℃, and detection wavelength was 214 nm. Conclusion ：The established capillary electrophoresis method for sep- arating sertraline hydrochloride and its isomers is simple and sensitive, which can be applied in the quality control and stability study.

关 键 词：盐酸舍曲林 5-羟色胺抑制剂 对映异构体 手性拆分 高效毛细管电泳 环糊精手性添加剂 光学纯度 

分 类 号：R917[医药卫生—药物分析学]