摘要:
目的:建立左旋麻黄碱中对映异构体杂质检查的毛细管电泳方法。方法:以SBE-β-CD和HP-β-CD二元环糊精为手性添加剂,探讨了环糊精种类及浓度、pH、有机溶剂种类等因素对麻黄碱及伪麻黄碱对映体拆分的影响,结果表明:毛细管:未涂渍熔融石英毛细管75μm×68 cm(有效长度60 cm)。分离用缓冲液为25 mmol/L的Tris缓冲液,含2.0%HP-β-CD和1.0%SBE-β-CD,用磷酸调节pH至3.0。分离电压16kV;温度15℃;虹吸进样:高度10 cm,时间3 s;紫外检测波长214 nm。结果:麻黄碱及伪麻黄碱对映体得到良好分离,并满足进行左旋麻黄碱中对映异构体杂质检查所需要的条件。结论:该方法简单可靠、专属性强,可以作为常规的杂质检查手段。
Abstract:
Objective : To develop a method for purity test and enantioseparation of ephedrine levorotatory by capillary electrophoresis(CE). Methods : The cyclodextrin,concentration,pH,organic solvent were studied,and the results indicated that the enantiomer of ephedrin and ephedrine levorotatory were baseline separated under the following experimental conditions:uncoated fused silica capillary(75 μm × 68 cm),25 mmol/L Tris,2% HP-β-CD and 1% SBE-β-CD,pH was adjusted at 3.0 by phosphoric acid,and 15 kV separation voltage.The detection wavelength was set at 214 nm with the column temperature of 15 ℃. Results : Under the experimental conditions adopted,the baseline separation of ephedrin and ephedrine levorotatory was obtained. Conclusions : The proposed method is simple,reliable and can be used for routine purity test and chiral separation.