Determination of residual organic solvents in levetiracetam by headspace gas chromatography

Objective:To establish a method for the determination of three kinds of residual organic solvents in levetiracetam by headspace gas chromatography.Methods:A wide bore HP-fast GC residual solvent column was chosen for separation with FID detector.The external standard method was used for quantitative analysis.Several factors affecting the headspace determination were studied,including analytical conditions,equilibrium temperature and equilibrium time.Results:The standard curves were linear in the range of 0.133~1.326μg·mL-1(r=0.9997) for dichloromethane,4.330~43.296μg·mL-1(r=1.0000) for ethyl acetate and 0.009~0.087μg·mL-1(r=0.9997) for toluene.The average recoveries for three residual organic solvents were between 99.70% and 102.46% with RSD(n=6) of precision in the range of 1.79%~3.05%.The detection limits of dichloromethane,ethyl acetate and toluene were 0.008,0.005 and 0.001μg·mL-1 respectively.Conclusion:The method is rapid,sensitive and accurate.