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毛细管柱气相色谱法测定盐酸金刚烷胺有关物质
引用本文:楼永军,陈爽,陶巧凤. 毛细管柱气相色谱法测定盐酸金刚烷胺有关物质[J]. 药物分析杂志, 2011, 0(3)
作者姓名:楼永军  陈爽  陶巧凤
作者单位:浙江省食品药品检验所;
摘    要:
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。

关 键 词:气相色谱法  盐酸金刚烷胺  有关物质  

GC determination and identification of related substances of amantadine hydrochloride
LOU Yong-jun,CHEN Shuang,TAO Qiao-feng. GC determination and identification of related substances of amantadine hydrochloride[J]. Chinese Journal of Pharmaceutical Analysis, 2011, 0(3)
Authors:LOU Yong-jun  CHEN Shuang  TAO Qiao-feng
Affiliation:LOU Yong-jun,CHEN Shuang,TAO Qiao-feng (Zhejiang Institute for Food and Drug Control,Hangzhou 310004,China)
Abstract:
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...
Keywords:GC  amantadine hydrochloride  related substances  
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