毛细管电泳法测定舒必利异构体

目的: 建立分离舒必利消旋体并准确检测左舒必利片剂中主药含量的毛细管电泳法。 方法: 采用熔融石英毛细管柱(50 μm×31 cm,有效长度为21 cm),以含2%高磺化α-环糊精的20 mmol· L^-1 柠檬酸钠缓冲溶液为运行缓冲液,检测波长为214 nm,分离电压为-10 kV。 结果: 实现了左舒必利和右舒必利的基线分离,左舒必利在0.001~0.1 mg·mL^-1 范围内线形关系良好,用建立的方法检测3批左舒必利片标示含量分别为97.08%,98.77%,98.78%。 结论: 本方法灵敏度高,简便快捷,适用于左舒必利片剂的含量测定和质量控制。

Objective: To develop a method for chiral separation of sulpiride enantiomers and determination of the levosulpiride content in tablets by capillary electrophoresis.Method: Fused silica capillary column(50 μm×31 cm,21 cm of effective length) was adopted,and 20 mmol·L^-1 citrate buffer solution containing 2% high sulfated-α-cyclodextrins was used as running buffer.The detection wavelength was set at 214 nm.The separation voltage was-10 kV.Results: Baseline separation of levosulpiride and dextrosulpiride was achieved.The linearity was excellent in the concentration ranged from 0.001-0.1 mg·mL^-1 for levosulpiride.The labeled contents of levosulpiride in samples were 97.08%,98.77%,and 98.78%,respectively.Conclusion: The established method is convenient and with high sensitivity,which can be applied for quality control of sulpiride tablets.