摘要
目的:对盐酸氮芥酊产生的降解产物进行结构解析,分析两种测定方法产生结果差异的原因和降解产物来源。方法:采用碘量法和气相色谱法测定降解产物的含量,采用GC-MS法对降解产物结构进行解析。结果:碘量法测定结果较气相色谱法偏高,降解产物为2-氯乙基-(2-乙氧基)-甲基胺,是由于盐酸氮芥与辅料发生反应而产生。结论:降解产物消耗滴定液使碘量法测定结果偏高,气相色谱法专属性强,建议生产企业进一步研究该品种生产工艺和贮藏条件,避免或降低样品与辅料发生反应。
Objective:To analyze the structure of degradation products of chlormethine hydrochloride tincture and the reasons for the differences between the results of the two methods and the sources of degradation products.Methods:The content of degradation products was determined by iodometry and gas chromatography,and the structure of degradation products was analyzed by GC-MS.Results:The results of iodometry were higher than those of gas chromatography.The degradation product was 2-chloroethyl-(2-ethoxy)-methylamine.The degradation product was produced by the reaction of chlormethine hydrochloride tincture with excipients.Conclusion:The degradation product consumes titration liquids,which makes the results of iodometry higher.Gas chromatography has better specificity.It is suggested that manufacturers should further study the production process and storage conditions of this variety to avoid or reduce the reaction between samples and excipients.
作者
李洁
李同辉
梁改玲
Li Jie;Li Tonghui;Liang Gailing(Henan Institute for Food and Drug Control,Zhengzhou 450018,China)
出处
《中国药事》
CAS
2020年第1期47-52,共6页
Chinese Pharmaceutical Affairs
关键词
盐酸氮芥酊
碘量法
气相色谱法
气质联用法
降解产物
chlormethine hydrochloride tincture
iodometry
gas chromatography
GC-MS
degradation product
作者简介
李洁,主任药师,研究方向:化学药品质量分析,Tel:(0371)65566621,E-mail:zhanglujieliying@163.com
