高效液相色谱法测定右旋糖酐40原料及其氯化钠注射液中糠醛含量

High-performance liquid chromatography in determining furfural in dextran 40 raw material and its sodium chloride injection

目的建立高效液相色谱法测定右旋糖酐40原料及其氯化钠注射液中糠醛的含量。方法色谱柱:MACHEREY-NAGEL C18(250mm×4.6mm,5μm);流动相:甲醇-水(磷酸调节pH值为3.0,体积比为1090);柱温:(35±5)℃;流速:1.0mL/min;检测波长:275nm。结果糠醛在0.01~10.10μg/mL质量浓度范围内与峰面积呈良好的线性关系,线性方程为Y=192 440.8 X-3 711.6(R=0.999 9),日间精密度RSD为0.5%;平均回收率为98.1%(RSD为0.3%),最低检测限为0.003μg/mL。右旋糖酐40原料中糠醛含量为0.071 10~1.306 0μg/g,右旋糖酐40氯化钠注射液中糠醛的含量为0.018 0~0.198 8μg/mL。结论该法简便、准确,适用于右旋糖酐40原料及其氯化钠注射液中糠醛的含量测定。

Objective To establish a high-performance liquid chromatography （HPLC） method for determining furfural in dextran 40 raw material and its sodium chloride iniection. Methods The chromatographic conditions adopted were as follows： a MACHEREY-NAGEL C18 （4.6 mmX250 mm, 5 μm）, a mobile phase of methanol-water （pH= 3.0, V ： V= 10 ： 90）, 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 t^g/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.