Determination of Residual Solvents in Terbinafine Hydrochloride by Gas Chromatography with Capillary Column

Gas chromatography with HP-5 capillary column (25 m×0.32 mm,0.25 μm) was applied to the determination of 6 residual solvents,i.e.ethyl ether,iso-propanol,ethyl acetate,chloroform,tetrahydrofuran and toluene,in the propylene drug,terbinafine hydrochloride.The dried sample was dissolved in dimethyformamide (DMF) and the residual solvents in the DMF solution were separated on the capillary column,and determined with FID detector using benzene as internal standard.Values of recovery of the six solvents,as a whole,were in the range from 92.7% to 101.0%.Values of RSD′s (n=6) found were in the range of 1.5%-2.8%.Detection limits (S/N=3) of 1.5,2.8,2.5,12.0,1.7 and 1.6 mg·L-1 were found for the 6 solvents respectively.