Determination of Residual of 1,4-Dioxane and 2-Methoxyethanol in Irsogladine Maleate Bulk Drug by GC

OBJECTIVE To establish a method for the determination of residual of 1,4-dioxane and 2-methoxyethanol in irsogladine maleate bulk drug by capillary gas chromatography(GC). METHODS Samples were dissolved in dimethyl formamide and separated on an HP-INNOWAX capillary column (30 m×0.53 mm, 1 μm) and detected by FID. The column temperature was programmed and initial temperature was 40 ℃. The injector temperature was 200 ℃ and the detector temperature was 250 ℃. RESULTS The linear ranges for 1,4-dioxane and 2-methoxyethanol were 7.6-76 μg·mL^-1(r=0.999 9) and 1.0-10 μg·mL^-1(r=0.998 4), respectively. Their average recoveries were 94.7%(RSD=3.7%) and 98.2%(RSD=3.9%). The limits of detection were 0.9 μg·mL^-1 and 0.3 μg·mL^-1, respectively. CONCLUSION The method is sensitive, accurate and can be used for the determination of residual organic solvents in irsogladine maleate bulk drug.