顶空气相色谱法测定左亚叶酸钠中离子交换树脂残留溶剂

Determination of ion exchange resin residual solvents in sodium levofolinate by headspace gas chromatography

目的建立了左亚叶酸钠中8种离子交换树脂有机溶剂残留物的检测方法。方法采用顶空气相色谱法。色谱柱为DB-624毛细管色谱柱（30．0m×0．53mm×3．00μm）；氢火焰离子化检测器；程序升温；载气：氮气；体积流量：2．5mL／min；项空加热温度：90℃；进样量：3mL。结果在该条件下，8种残留溶剂完全分离，且在2～40μg／mL线性关系良好，平均回收率在81．73％～108．20％。结论此法操作简单快捷，灵敏度高，结果准确可信，可用于左亚叶酸钠中离子交换树脂残留溶剂检测。

Objective To establish a method for detecting eight residues of organic solvent in sodium levofolinate by ion exchange resin. Methods Headspace gas chromatography with DB-624 capillary column （30.0 m ×0.53 mm, 3.00 μm） and FID detector were used with temperature program. Carder gas was nitrogen, and the flow rate was 2.5 mL/min. The headspace temperature was set at 90 ℃ with the injection volume of 10 μL. Results The organic residues were completely separated. There was a good linearity in the range of 2 - 40 μg/mL. The average recoveries of the eight residues were in the range of 81.73% - 108.20%. Conclusion The method is simple, sensitive, and accurate. It could be used for detecting the residual solvents in sodium levofolinate.