气相色谱法测定氨茶碱及其制剂中乙二胺的含量  

GC determination of ethylenediamine in aminophylline and its preparations

作　　者：陈赞民 陈颖江[1] 

机构地区：[1]海南省药品检验所,海口570216

出　　处：《药物分析杂志》2012年第9期1673-1676,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立氨茶碱及其制剂中乙二胺的含量测定方法。方法:采用气相色谱法,用DB-624毛细管气相色谱柱(30 m×0.53 mm,3.0μm),程序升温(120℃保持7 min,以80℃.min-1上升至250℃,保持5 min),进样口温度180℃,检测器为FID,检测器温度250℃,内标为甲基异丙基酮。结果:乙二胺的线性范围为0.1193～0.5964 mg.mL-1(r=0.9995),理论板数大于10000,各相邻峰分离度均大于1.8,精密度、回收率的RSD均小于2.0%。结论:方法简单、准确,灵敏度高,重复性好,适用于氨茶碱及其制剂中乙二胺含量的测定。Objective：To establish a method for the determination of ethylenediamine in aminophylline bulk and pharmaceutical formulations. Methods：The GC method for determination of ethylenediamine was conducted on a DB-624 capillary column （30 m ×0. 53 mm,3.0 μm）. The column temperature was maintained at 120℃ for 7 rain, and programmed to 250℃ at the rate of 80 ℃· min - ] , then held for 5 min. The injector temperature was 180 ℃ , and the FID detector temperature was 250℃. Methyl isobutyl ketone was used as internal standard. Results： It appeared a good linearity in the range of 0. 1193 -0. 5964 mg · mL ]（r = 0. 9995）. The numbers of theoretical plates were more than 10000 and the resolutions between each adjacent peak were more than 1.8. The RSDs of pre- cision and accuracy were all less than 2.0%. Conclusion：The method is simple, accurate,precise and reproducible. It can be used for the determination of ethylenediamine in bulk and pharmaceutical formulations.

关 键 词：氨茶碱原料药 氨茶碱注射剂 氯茶碱片剂 直接进样法 乙二胺含量测定 甲基异丙基酮内标法 

分 类 号：R917[医药卫生—药物分析学]