气相色谱法测定氨茶碱及其制剂中乙二胺的含量

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,3.0 μm),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 min,and programmed to 250℃ at the rate of 80℃·min^-1,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^-1(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 precision and accuracy were all less than 2.0%. Conclusions:The method is simple,accurate,precise and reproducible.It can be used for the determination of ethylenediamine in bulk and pharmaceutical formulations.

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