气相色谱法测定培美曲塞二钠中三乙胺、N,N-二甲基乙酰胺的残留量
Determination of Triethylamine and N,N-dimethylacetamide Residues in Pemetrexed Disodium by GC
常梦茹 1姚彤 2欧仁珊 2吉敬1
作者信息
- 1. 江苏海洋大学 药学院,江苏 连云港 222005
- 2. 连云港杰瑞药业有限公司,江苏 连云港 222006
- 折叠
摘要
目的:建立培美曲塞二钠中三乙胺、N,N-二甲基乙酰胺残留量的测定方法.方法:三乙胺采用DB-1色谱柱,N,N-二甲基乙酰胺采用DB-WAX色谱柱,检测器温度250℃,程序升温.结果:三乙胺和N,N-二甲基乙酰胺在各自的浓度范围内线性关系良好(R2＞0.995),平均回收率分别为99.38%、96.40%.结论:该方法准确、可靠、灵敏,可用于培美曲塞二钠原料药中残留溶剂三乙胺、N,N-二甲基乙酰胺的含量测定.
Abstract
Objective:To establish a method for the determination of triethylamine and N,N-dimethylacetamide in pemetrexed disodium(API).Method:Triethylamine is detected by DB-1 column,N,N-dimethylacetamide is detected by DB-WAX column,the detector temperature is 250℃,program temperature.Results:Triethylamine and N,N-dimethylacetamide had good linearities within their respective concentration ranges(R2＞0.995),with average recoveries of 99.38%and 96.40%.Conclusion:The method is accurate,reliable,and sensitive,suitable for the determination of triethylamine and N,N-dimethylacetamide in the drug substance of Pemetrexed Disodium.
关键词
培美曲塞二钠/残留溶剂/三乙胺/N,N-二甲基乙酰胺/气相色谱法Key words
pemetrexed disodium/residual solvents/triethylamine/N,N-dimethylacetamide/GC引用本文复制引用
出版年
2024
NETL
NSTL
万方数据