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目的建立硼替佐米光学异构体高效液相手性分离方法。方法在Chiralpak AD-H[直链淀粉-三(3,5-二甲基苯基氨基甲酸酯)手性固定相]手性柱上拆分硼替佐米异构体,考察流动相中不同浓度的异丙醇与乙醇、柱温和流速对手性拆分的影响。结果最佳拆分流动相组成为正己烷和改性调节剂,最佳色谱条件为正己烷-异丙醇-乙醇(86∶6∶8),流速为0.6 mL·min?1,柱温30℃。结论本方法可方便地拆分硼替佐米异构体,为硼替佐米原料药质量标准和质量控制提供了科学依据。
Objective To establish a high performance liquid chiral separation method for bortezomib optical isomers. Methods Bortezomib isomers were resolved on a Chiralpak AD-H [amylose-tris (3,5-dimethylphenylcarbamate) chiral stationary phase] chiral column and examined for differences in mobile phase Concentration of isopropanol and ethanol, column temperature and flow rate on chiral resolution. Results The optimum mobile phase consisted of n-hexane and modifier. The optimum conditions were n-hexane-isopropanol-ethanol (86:6:8), flow rate 0.6 mL · min -1, column temperature 30 ℃. Conclusion This method can be easily resolved bortezomib isomers, bortezomib API quality standards and quality control provides a scientific basis.