LC-Q-TOF/MS方法分析氢溴酸高乌甲素及其注射剂中有关物质

目的：研究氢溴酸高乌甲素及其注射剂中有关物质。方法：建立HPLC方法对2批氢溴酸高乌甲素原料药及21批注射剂中的有关物质进行了考察，采用LC-Q-TOF/MS技术对主要有关物质的结构进行了初步鉴定。结果：氢溴酸高乌甲素原料药及其注射剂中主要存在6个有关物质，分别为高乌宁辛、N-去乙酰基高乌甲素、冉乌头碱、异刺乌头碱、9-去氧基刺乌头碱和刺乌宁。其中刺乌宁为氢溴酸高乌甲素酯键水解的降解产物，其余杂质来源于原植物。结论：建立的方法能有效地分离主成分氢溴酸高乌甲素与有关物质，为氢溴酸高乌甲素原料药及其注射剂的质量控制、工艺优化及贮存提供参考。

Objective: To study the related substances in lappaconite hydrobromide (LH) and its injection. Methods: An HPLC method was established to study the related substances in 2 batches of LH (API) and 21 batches of its injection.Q-TOF/MS technique was used to identify the structure of the related substances. Results: The study showed that there were six major related substances in LH and its injections include sinomontanine H,N-deacetylfinaconitine,ranaconitine,isolappaconitine,9-deoxylappaconitine and lappaconine.Lappaconine was a product of LH ester bond hydrolysis,and the five others were from the original plants. Conclusion: The established method can effectively separate and identify the principal components and the related substances in LH,which provides a reference for the quality control,process optimization and storage.

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