Determination of residual organic solvents in a new pharmaceutical-developing(UP0044) by capillary gas chromatography

A method for determining contents of seven kinds of residual organic solvents such as methanol,ethanol,methylene chloride,ethyl aetate,toluene,tetrahydrofuran and acetic acid in a new pharmaceutical-developing(UP0044) was established by capillary gas chromatography.The experimental conditions were DB-624 silica capillary column,FID detector,carrier helium gas and external standard calibration method.The results indicated that the seven residual solvents were separated completely and the linearity were good(R20.99).Average recovery was 90%—110%,RSD was 1.2%—8.8%.The lowest detection limit was 0.9×10-6—1.69×10-4.Both methanol and ethanol solvents were detected in 4 batches of the UP0044,but other solvents was no done.