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目的:建立葡萄糖酸亚铁口服溶液中5-羟甲基糠醛的含量测定方法。方法:高效液相色谱法,采用C18(250×4.6mm,5μm)色谱柱;以0.02mol/L磷酸二氢钾溶液(用磷酸调节p H值至4.5)-甲醇(60:40)为流动相;流速1.0m L·min-1;检测波长284nm。结果:在1.0191μg·m L-1~40.7630μg·m L-1浓度范围内5-羟甲基糠醛的峰面积和浓度具有良好的线性关系,R=1.00000;平均回收率为100.56%,RSD=0.79%(n=9)。结论:本方法准确、可靠、重复性好,适用于葡萄糖酸亚铁口服溶液的5-羟甲基糠醛的含量控制。
Objective: To establish a method for the determination of 5-hydroxymethylfurfural in ferrous gluconate oral solution. METHODS: High performance liquid chromatography (HPLC) was performed on a C18 (250 × 4.6 mm, 5 μm) column. The mobile phase was eluted with 0.02 mol / L potassium dihydrogen phosphate (pH = 4.5 with phosphoric acid) Phase; flow rate 1.0m L · min-1; detection wavelength 284nm. Results: There was a good linear relationship between the peak area and the concentration of 5-hydroxymethylfurfural in the concentration range of 1.0191μg · m L-1 to 40.7630μg · m L-1, R = 1.00000; the average recovery was 100.56%, RSD = 0.79% (n = 9). Conclusion: The method is accurate, reliable and reproducible. It is suitable for the content control of 5-HMF in the oral solution of ferrous gluconate.