Abstract:
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×0.25 μm). 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 30 min, 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.