GC测定拉科酰胺原料药中的5种残留溶剂

目的建立顶空进样气相色谱法检测拉科酰胺原料药中5种残留溶剂的方法。方法采用顶空毛细管气相色谱法，色谱柱为AgilentHP-5石英毛细管柱（30．0m×0．32mm×0．25μm）；进样口温度：210℃；FID检测器温度：240℃；柱温：50℃；载气：氮气；流速：1．0mL·min^-1。顶空进样，顶空平衡温度：85℃，顶空平衡时间：30min；进样体积：0．35mL。结果在上述条件下，5种残留溶剂均能良好分离，各溶剂峰面积与浓度均呈良好的线性关系，方法精密度良好，回收率均较为理想。结论该法适用于拉科酰胺原料药中残留溶剂的测定。

Determination of Five Residual Organic Solvents in Lacosamide by GC

OBJECTIVE To establish a headspace gas chromatography method for determination of residual solvents in lacosamide. METHODS Headspace gas chromatography was added using an Agilent HP-5 capillary column（30.0 m× 0.32 mm×0.25μm）. The column temperature was 50 ℃ with nitrogen gas as carrier and FID as detector. The flow of carrier was 1.0 mL·min^-1. The injection port and detector temperature were 210 ℃ and 240℃, respectively. The heated temperature of the headspace oven was 85 ℃, the heated time lasted 30min, and the injection volume was 0.35 mL. RESULTS Each solvent could be completely separated in chromatogram obtained from systemic suitability test, and the calibration curves of each solvent had good linear relationship within a certain range. CONCLUSION The method is accurate and reliable. It can be applied in determination of residual solvents in lacosamide.