GC法检测培美曲塞二钠原料药中4种有机溶剂残留量

目的:建立以气相色谱法检测培美曲塞二钠中4种有机溶剂残留量的方法。方法:采用气相色谱法检测培美曲塞二钠中二氯甲烷、N,N-二甲基甲酰胺(DMF)、丙酮、乙醇4种溶剂残留量。其中二氯甲烷、DMF采用DB-1石英毛细管柱,以四氢呋喃(THF)为内标进行定量;丙酮、乙醇采用PEG-20M石英毛细管柱,分别与其标准品对照来进行定量。结果:二氯甲烷、DMF、丙酮、乙醇的检测浓度线性范围分别为11.4～171、14.76～221.4、20～300、20～300μg·mL-(1r均>0.9990),回收率为100.9%～101.5%,RSD为0.4%～2.2%。样品中4种溶剂均未检出。结论:本方法简单、准确、灵敏度高、重复性好。

Determination of 4 Kinds of Residual Organic Solvents in Pemetrexed Disodium by GC

OBJECTIVE：To establish GC method for the content determination of 4 kinds of residual organic solvents in pemetrexed disodium.METHODS：GC was used to determine the contents of residual organic solvents in pemetrexed disodium,such as dichloromethane,DMF,acetone and ethanol.DB-1 capillary column was used to detect dichloromethane and DMF with tetrahydrofuran（THF） as internal standard.PEG-20M capillary column was used to detect acetone and ethanol with their standard substances as external standard.RESULTS：The linear ranges were 11.4～171 μg·mL^-1 for dichloromethane,14.76～221.4 μg·mL^-1 for DMF,20～300 μg·mL^-1 for acetone and 20～300 μg·mL^-1 for ethanol（r〉0.999 0）.Recoveries were between 100.9% and 101.5% and RSD ranged from 0.4% to 2.2%.4 kinds of solvents hadn＇t been detected in samples.CONCLUSION：The method is simple,accurate,sensitive and reproducible.