[关键词]
[摘要]
目的 鉴定消旋山莨菪碱未知杂质。方法 采用多种色谱、光谱方法联合对消旋山莨菪碱中的未知杂质进行分析,确定未知杂质结构。结果 消旋山莨菪碱在存储过程中因水解而产生杂质,经过高效液相色谱法、液相色谱-质谱联用技术、薄层色谱法和核磁共振技术鉴定,杂质为6β-羟基托品和托品酸。结论 消旋山莨菪碱中的杂质为水解产物6β-羟基托品和托品酸,应对这两种杂质进行质量控制。
[Key word]
[Abstract]
Objective To identify the impurity of racanisodamine.Methods Several chromatographic and spectroscopic methods were used to analyze and identify the unknown impurities in racanisodamine.Results During storage, the impurities were produced by hydrolysis of racanisodamine. The impurities were 6β-hydroxy tropine and tropine acid after identifying by HPLC, LC-MS, TLC and NMR.Conclusion 6β-hydroxy tropine and tropine acid were hydrolysis products of racanisodamine, which were the impurities. The quality control of the two impurities should be carried out.
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[基金项目]
国家自然科学基金项目(81403071);北京市自然科学基金项目(7172130);北京中医药大学自主课题项目(2017-JYB-XS-075)