气相色谱法测定培美曲塞二钠中有机溶剂残留量

目的：建立培美曲塞二钠中有机溶剂残留量的气相色谱分析方法。方法：选用OV-101毛细管色谱柱为分离柱，FID检测器，外标法进行定量，并对分离条件进行了研究。结果：二氯甲烷、四氢呋喃、N，N-二甲基甲酰胺的线性范围分别为5．1～50．6μg／ml（r=0．9997）、8．1-81．2μg／ml（r=0．9996）、7．5-75．2μg,／ml（r=0．9997）；平均回收率分别为99．74％、101．94％、100．58％；RSD分别为1．40％、2．07％、2．56％（n=6）；检测限分别为0．4、0.4、1．7μg/ml。结论：该方法快速、灵敏、准确，可作为培美曲塞二钠中有机溶剂残留量的测定方法。

Determination of residual organic solvents in pemetrexed disodium by gas chromatography

Objective： To establish a method for the determination of three kinds of residual organic solvents in pemetrexed disodium by gas chromatography. Methods： A non-polar stationary phase GC column was chosen for separation with FID detector. The external standard method was used for quantitative analysis. Analytical conditions were studied. Results： The standard curves were linear in the range of 5.1-50.6μg/ml （r=0.999 7） for dichloromethane, 8.1-81.2 μg/ml （r=0.999 6） for tetrahydrofuran and 7.5-75.2 μg/ml （r=0.999 7） for dimethyl formamide. The average recoveries for the three residual organic solvents were 99.74%,101.94% and 100.58% with RSD of 1.40%, 2.07% and 2.56% （n=6）. The detection limits of dichloromethane, tetrahydrofuran and dimethyl formamide were 0.4, 0.4 and 1.7 μg/ml, respectively. Conclusion： The method is rapid, sensitive, accurate and can be used for detecting residual organic solvents in pemetrexed disodium.