Abstract:Objective To establish a high-performance liquid chromatography (HPLC) method for determining furfural in dextran 40 raw material and its sodium chloride injection. Methods The chromatographic conditions adopted were as follows: a MACHEREY-NAGEL C18 (4.6 mm×250 mm, 5 μm), a mobile phase of methanol-water (pH=3.0, VV=1090), the column temperature at (35±5)℃, the flow rate at 1.0 mL/min, and the detection wavelength at 275 nm. Results The calibration curve was linear within the concentration range of 0.01-10.10 μg/mL, with the regression equation being Y=192 440.8X-3 711.6 (R=0.999 9), and the inter-day RSD was 0.5%; the average recovery rate was 98.1% (RSD being 0.3%), with the limit of detection (LOD) being 0.003 μg/mL. The level of furfural was 0.071 10-1.306 0 μg/g in dextran 40 raw material and 0.018 0-0.198 8 μg/mL in the dextran 40 sodium chloride injection. Conclusion The method of this study is simple and accurate, and can be used for determining the levels of furfural in dextran 40 raw material and its sodium chloride injection.