Abstract:To establish a standard method for the determination of residual solvents in pharmaceutical packaging materials.Methods: Gas chromatography was performed with chromatographic column of DM – WAX (30 mm×0.25 mm×0.25 μm) and the temperatures of injection port and hydrogen flame ionization detector were set at 160 ℃ and 220 ℃ respectively.Temperature programme: the column temperature rose to 30 ℃ and hold for 10 mins; rose by 10 ℃ per minute from 30 ℃ to 90 ℃,and hold for 2 minutes,then by 90 ℃ per minute to 160 ℃ and hold for 5 minutes.n-hexane was the internal standard when determinating the content of residual solvents in different pharmaceutical packaging materials.Results: Acetone,ethyl acetate,butanone,isopropyl alcohol,benzene,toluene regression equations were Y=3.5638X+0.0120,Y=3.6619X+0.0099,Y=4.9390X+0.0104,Y=3.7315X+0.0042,Y=10.112X+0.0291,Y=10.258X+0.0370 respectively.The residual solvents in Montmorillonite powder packaging material is toluene,the average recovery is 97.2%,RSD=1.41%.Conclusion: The method is accurate,reproducible,high sensitivity,and can be used for the determination of residual solvents in pharmaceutical packaging materials.