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

作　　者：常梦茹 姚彤 欧仁珊 吉敬 Chang Mengru;Yao Tong;Ou Renshan;Ji Jing(School of Pharmacy,Jiangsu Ocean University,Lianyungang 222005,China;JARI Pharmaceutical Co.,Ltd.,Lianyungang 222006,China)

机构地区：[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

出　　处：《广东化工》2024年第10期140-142,共3页Guangdong Chemical Industry

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(R^(2)>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。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(R^(2)>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 

分 类 号：R917[医药卫生—药物分析学]