毛细管柱气相色谱法测定盐酸金刚烷胺有关物质

GC determination and identification of related substances of amantadine hydrochloride

目的:建立气相色谱法测定盐酸金刚烷胺的有关物质并对有关物质进行确证。方法:采用毛细管柱,程序升温,FID检测器测定有关物质;采用MSD检测器,测得有关物质的EI质谱图,进行结构确证。结果:通过方法学验证,可以采用面积归一化法测定有关物质,检测限为2 ng;并确证了杂质A为二氨基取代金刚烷,杂质B为2-氨基金刚烷。结论:本方法准确、灵敏,可以控制盐酸金刚烷胺的质量。

Objective：To establish a GC method for determination and identification of related substances of amantadine hydrochloride. Methods：The related substances are analyzed with programmed temperature in a HP-5 capillary column by FID,and identified by means of mass spectrum obtained from impurities. Results：The area normalization method for determination of related substances of amantadine hydrochloride is validated,the limit of detection is 2 ng,the impurity A is amino-disubstituted adamantane,the impurity B is 2-aminoadamantane. Conclusion：The method is reliable and sensitive,and can be used for quality control of amantadine hydrochloride.