Determination of the contents of residual organic solvents in moracizine hydrochloride by capillary gas chromatography with headspace sampling

Objective To establish a headspace GC method for the determination of residual organic solvents-methanol,alcohol,isopropyl alcohol,dichloromethane,ethyl acetate,tetrahydrofuran,and methylbenzene in moracizine hydrochloride.Methods The residual organic solvents were separated on DB-624 capillary column using temperature programming.FID was used as detector with a temperature of 250 ℃,the inlet temperature was 150 ℃,and water as the solvent.Results The linear ranges of methanol,alcohol,isopropyl alcohol,dichloromethane,ethyl acetate,tetrahydrofuran,and methylbenzene were 12.0-240 mg·L-1(r=1.000 0),10.0-200 mg·L-1(r=0.999 9),10.0-200 mg·L-1(r=0.999 9),1.20-24 mg·L-1(r=0.999 9),10.0-200 mg·L-1(r=0.999 9),1.44-28.8 mg·L-1(r=0.999 8),1.78-35.6 mg·L-1(r=0.999 7),respectively.The average recoveries were ranged from 98.1% to 99.5% with RSD ranged at 0.6%-1.7%.The determination limits were 0.22-11.91 mg·L-1.The residual levels for the seven organic solvents in 3 batches samples met standard that stipulated in China pharmacopeia.Conclusions The method is simple,accurate,sensitive and reproducible;it can be used for the determination of the residual organic solvents in moracizine hydrochloride.