| 引用本文: | 邹华生,郑璐,姚书杨,吴斌,张益波.正相HPLC-直链淀粉手性固定相拆分硼替佐米及其光学异构体[J].中国现代应用药学,2014,31(4):449-452. |
| ZOU Huasheng,ZHENG Lu,YAO Shuyang,WU Bin,ZHANG Yibo.Separation of Bortezomib and Its Optical Isomers on Amylose Chiral Stationary Phase by NP-HPLC[J].Chin J Mod Appl Pharm(中国现代应用药学),2014,31(4):449-452. |
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| 摘要: |
| 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。 |
| 关键词: 高效液相色谱法 手性固定相 硼替佐米 异构体 Chiralpak AD-H |
| DOI： |
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| 基金项目:“重大新药创制”国家科技重大专项(2011ZX09202-101-29) |
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| Separation of Bortezomib and Its Optical Isomers on Amylose Chiral Stationary Phase by NP-HPLC |
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ZOU Huasheng, ZHENG Lu, YAO Shuyang, WU Bin, ZHANG Yibo
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Yangtze River Pharmaceutical Group Shanghai Heini Pharmaceutical Co., Ltd. Shanghai 201318, China
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| Abstract: |
| OBJECTIVE To develop a normal phase HPLC method for the separation of bortezomib and its optical isomers. METHODS The chiral separation of bortezomib and its optical isomers on amylase tris (3,5-dimethylphenylcarbamate) chiral stationary phase was carried out. The effectes of different proportions of n-hexane/isopropanol/ethanol in mobile phase were investigated, and the flow rate of mobile phase and column temperature were also optimized. RESULTS The mobile phase of the established method was n-hexane-isopropanol-ethanol(86∶6∶8), with the flow rate of 0.6 mL·min-1. The column temperature was set at 30 ℃. CONCLUSION The method is simple, rapid and can be used for analysis of bortezomib and its optical isomers. |
| Key words: HPLC chiral stationary bortezomib isomer Chiralpak AD-H |
