Simultaneous Determination of 9 Residual Solvents in Vitamin B1 Tablets by Headspace-Gas Chromatography
Objective To establish a gas chromatographic separation and determination method for 9 residual organic solvents in vitamin B1 tablets,including methanol,ethanol,acetone,ethyl formate,acetonitrile,n-hexane,ethyl acetate,tetrahydrofuran and n-heptane.Methods Using headspace capillary gas chromatography,a capillary column with 6%(V/V)cyanopropylphenyl-94%(V/V)dimethylpolysiloxane(DB-624)as the stationary phase was used(30 m×0.530 mm×3.00 μm),The detector was FID,the carrier gas was nitrogen,and the solvent was DMF:water(1:1).The residual solvent content was calculated using the external standard method.Results All 9 organic solvents were effectively separated and showed a good linear relationship,with a correlation coefficient greater than 0.999 64;the average recovery rate ranges from 92.2%-111.7%(n=9);the precision RSD was within 0.3%-1.0%(n=6).Conclusion This method has good separation effect,sensitivity,reliability,and accuracy,and is suitable for the simultaneous determination of 9 residual solvents in vitamin B1 tablets.
Vitamin B1 tabletsHeadspace injectionCapillary gas chromatographyDetermination of residual solvents
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