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

LC- Q- TOF / MS analysis of related substances in lappaconite hydrobromide and its injection

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.