建立了匹伐他汀钙对映体的毛细管区带电泳(CZE)拆分方法。分别考察了电泳电压,缓冲溶液种类、浓度及pH值,环糊精种类及浓度,添加剂种类及浓度等参数对实验结果的影响,从而确定了匹伐他汀钙对映体的最佳拆分条件:电泳电压为18kV;运行缓冲溶液为80mmol/L的Tris-HCl缓冲体系,pH值为3.20,其中含有50mmol/LHP-β-CD(羟丙基-β-环糊精)和5mmol/LSDS(十二烷基磺酸钠);采用重力进样,进样高度17cm,进样时间为2s。在优化的实验条件下,匹伐他汀钙对映体得到了较好的分离,分离度可达2.17。实验结果表明该方法可用于匹伐他汀钙对映体的分离,具有快速、便捷、准确性好等优点。
A method of capillary zone electrophoresis(CZE)has been established for the chiral separation of pitavastatin calcium enantiomers.Several parameters,such as the running voltage,the composition and the pH value of the running buffer,the types of additive and so on,were evaluated.The optimal separation conditions were as follows:capillary,53 cm(45 cm effective length,50μm);running buffer,80 mmol/L Tris-HCl,pH3.20,which contained 50 mmol/L HPβ-CD(hydroxypropyl-β-cyclodextrin)and 5 mmol/L SDS(sodium dodecylsulphate);applied voltage,18 kV(54μA);column temperature,23℃;injection,2 s at the height of 17 cm.Under these conditions,pitavatatin calcium enantiomers were separated well with the resolution of 2.17.The results indicate that this method is rapid,simple,accurate and suitable for the chiral separation of pitvatin calcium enantiomers.