【摘要】 目的:建立盐酸昂丹司琼的高效毛细管电泳的手性分离方法。方法:通过手性拆分剂的种类及浓度、缓冲液的pH及浓度、温度及电压的优化,选择最佳的手性分离条件。结果:最佳分离条件缓冲液为33 mmol.L-1三羟甲基氨基甲烷(Tris)(用磷酸调节pH 2.2,含30 mg.mL-1羧甲基-β-环糊精);检测波长为214 nm;电压为30 kV;温度为25℃,基线分离了盐酸昂丹司琼的2个对映体。结论:新建立的方法可用于这一新药研究开发过程中的产品质量控制。更多还原

【Abstract】 Objective: To establish a capillary electrophoresis method for chiral separation of ondansetron hydrochloride.Methods: The kinds and concentration of cyclodextrin,the pH value and concentration of buffer,the voltage and temperature were selected to optimize the conditions of chiral separation.Results: The optimal separation conditions were a 33 mmol·L-1 Tris buffer containing carboxymethyl-β-cyclodextrin(30 mg·mL-1),detection at 214 nm,voltage at 30 kV and separation temperature at 25 ℃.The separation of ondansetron hydrochloride enantiomers was achieved in the optimal conditions.Conclusion: The newly established method can be used in quality control of products in new drug development process.更多还原