毛细管电泳分离手性药物罗格列酮钠对映体的方法研究

Chiral Separation of Rosiglitazone Sodium by Aqueous/Nonaqueous Capillary Electrophoresis

以环糊精及其衍生物为手性选择剂,通过优化缓冲液的浓度、酸度以及采用环糊精的种类和浓度等,建立了罗格列酮钠对映体的水介质和非水介质两种毛细管电泳拆分方法。最佳条件为:150 mmol/LTris-H3PO4缓冲液,pH=2.0,含有1 mmol/Lβ_CD或DM_β_CD,10%(φ)甲醇的运行液,分离电压为25 kV,检测波长215 nm。也可以使用含有9 mmol/L HDMS_β_CD,20 mmol/L磷酸和10 mmol/L NaOH的甲醇电泳液。两种拆分体系均实现了罗格列酮钠对映体的基线分离,而且拆分效率基本相当。方法简便、快速,可作为罗格列酮钠的手性分离方法。

HPCE methods for separating and determining the rosiglitazone sodium enantiomers were established. The effects of buffer concentration, pH, and the type and concentrations of CDs in the chiral separation of rosiglitazone sodium were investigated. The buffer solution used in aqueous capillary electrophoresis （ACE） was 150 mmol/L Tris - H3O4 solution, pH = 2.0, containing 1 mmol/L β-CD or DM-β-CD, and 10% （ψ） methanol. The voltage applied was 25 kV, and the detective wavelength was 215 nm. In addition, a simple method for the separation of rosiglitazone sodium enantiomers was described by nonaqueous capillary electrophoresis （NACE） after establishing suitable separation conditions. Under the experiment conditions adopted, the baseline separation of rosiglitazone sodium enantiomers was obtained by the two methods. The proposed methods were simple, rapid and accurate, and could be used for the chiral separation of rosiglitazone sodium.