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季德, 刘云飞, 王巧晗, 张春凤, 杨中林. 川续断皂苷 VI 中有关物质的分离、结构鉴定与含量测定[J]. 中国天然药物, 2013, 11(4): 419-426.
引用本文: 季德, 刘云飞, 王巧晗, 张春凤, 杨中林. 川续断皂苷 VI 中有关物质的分离、结构鉴定与含量测定[J]. 中国天然药物, 2013, 11(4): 419-426.
shu
JI De, LIU Yun-Fei, WANG Qiao-Han, ZHANG Chun-Feng, YANG Zhong-Lin. Isolation,structure characterization and quantification of related impurities in asperosaponin VI[J]. Chinese Journal of Natural Medicines, 2013, 11(4): 419-426.
Citation: JI De, LIU Yun-Fei, WANG Qiao-Han, ZHANG Chun-Feng, YANG Zhong-Lin. Isolation,structure characterization and quantification of related impurities in asperosaponin VI[J]. Chinese Journal of Natural Medicines, 2013, 11(4): 419-426.
shu

川续断皂苷 VI 中有关物质的分离、结构鉴定与含量测定

Isolation,structure characterization and quantification of related impurities in asperosaponin VI

    摘要
  • 摘要: 目的:研究川续断皂苷VI原料药中的有关物质,并建立其高效液相色谱含量测定方法。方法:采用反相柱层析与半制备液相对有关物质进行分离纯化,用TOF-MS、IR和NMR技术进行结构鉴定,并建立了HPLC含量测定方法对川续断皂苷VI及其杂质进行含量测定。结果:从川续断皂苷VI原料药中分离得到7个有关物质。其中杂质3为两个互变异构体的混合物,该化合物为首次报道。HPLC方法学验证结果表明,该方法灵敏、准确、专属性强。结论:新建立的HPLC方法适用川续断皂苷VI及其有关物质的含量测定,能准确反映川续断皂苷VI原料药的质量。

     

    Abstract: AIM:To study the related impurities in asperosaponin VI bulk drug and to develop a high performance liquid chromatography(HPLC) method for the determination of asperosaponin VI and its related impurities.METHODS:The related impurities were detected in asperosaponin VI bulk drug by a newly developed HPLC method,obtained by ODS column chromatography and semi-preparative HPLC methods,and the structures were elucidated by TOF-MS,IR,and NMR techniques.The HPLC method was validated according to ICH guidelines for asperosaponin VI and its related impurities.RESULTS:Seven related impurities(Imp 1-7) were isolated from asperosaponin VI bulk drug.Impurity 3 was found to be a mixture of two epimers,and was first reported in the paper.The validation results showed good sensitivity,specificity,linearity(r20.997 9),precision(RSD5.0%),accuracy(recoveries in the range of 94.61%-106.51%) and robustness.CONCLUSION:The developed HPLC method is suitable for the quality control of asperosaponin VI bulk drug.

     

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