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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 capillary zone electrophoresis method for the separation of sertraline hydrochloride by chiral separation and check the optical purity. Methods: Uncoated quartz capillary (50 cm × 50 μm, effective length 40 cm) was used to investigate the effect of chiral selector type, concentration, buffer type, pH and separation voltage on chiral resolution. Separation conditions. Results: The separation conditions of sertraline hydrochloride enantiomers were as follows: 25 mmol·L-1 phosphate-triethanolamine (pH 2.50, containing 3% β-cyclodextrin sodium sulfate) as running buffer ; Detection wavelength of 214 nm; operating voltage of -20 kV, temperature of 25 ℃. CONCLUSION: This capillary electrophoresis method can separate the four isomers of sertraline hydrochloride on the baseline, and can effectively check the optical purity of sertraline hydrochloride. This method can be used for the quality control of isomer impurities of this raw material and its related preparations and Stability studies.