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目的:建立西孟旦的对映体拆分和对映体光学纯度测定方法。方法:使用Kromasil CHI-TBB手性固定相,以正己烷-异丙醇(85～92.5:7.5～15)为流动相,流速1.5 mL·min~(-1),检测波长380nm;流动相中添加0～0.2％乙酸作改性剂,直接拆分了药物西孟旦的对映体,考察了流动相组成和极性添加剂对对映体拆分的影响。结果:结果显示,这种以酒石酸二酰胺为手性中心的手性固定相,在正相条件下,可以对上述药物对映体实现基线拆分。并且通过改变流动相组成,在对映体分离因子基本不变的情况下,可以调节对映体的分高度和保留时间。结论:拆分了药物西孟旦对映体,测定了左旋西孟旦的对映作过量百分率。
OBJECTIVE: To establish a method for the determination of enantiomer separation and enantiomeric optical purity of simendan. Methods: Kromasil CHI-TBB chiral stationary phase was used with a mobile phase of n-hexane-isopropanol (85-92.5: 7.5-15) at a flow rate of 1.5 mL · min -1 with a detection wavelength of 380 nm. The enantiomers of simendan were separated directly by adding 0 ~ 0.2% acetic acid as modifier. The effects of mobile phase composition and polar additives on enantiomeric separation were investigated. Results: The results show that this chiral stationary phase with tartaric acid diamide as a chiral center can achieve baseline resolution of the above enantiomers under normal phase conditions. And by changing the composition of the mobile phase, the enantiomeric separation height and retention time can be adjusted while the enantioseparation factor is basically unchanged. Conclusion: The enantiomer of levosimendan was separated from the enantiomer of levosimendan. The enantiomeric excess of levosimendan was determined.