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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。
Objective: To establish a method for the determination of four organic solvents in pemetrexed disodium by gas chromatography. Methods: Gas chromatography was used to determine the residual solvents of methylene chloride, N, N-dimethylformamide (DMF), acetone and ethanol in pemetrexed disodium. Methylene chloride and DMF were quantified by using DB-1 quartz capillary column with tetrahydrofuran (THF) as internal standard. Acetone and ethanol were quantified by PEG-20M quartz capillary column, respectively. Results: The linear ranges of dichloromethane, DMF, acetone and ethanol were 11.4 ~ 171, 14.76 ~ 221.4, 20 ~ 300 and 20 ~ 300μg · mL- (1r> 0.9990) respectively. The recoveries were 100.9% ~ 101.5 %, RSD is 0.4% ~ 2.2%. None of the 4 solvents were detected in the sample. Conclusion: The method is simple, accurate, sensitive and reproducible.