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目的建立测定混合糖电解质注射液中5-羟甲基糠醛含量的高效液相色谱(HPLC)法。方法色谱柱:Welch Topsil C18柱(250 mm×4.6 mm,5μm),柱温:35℃,流动相:0.05 mol·L~(-1)磷酸二氢钾-乙腈(90∶10,V/V),流速:0.8 mL·min~(-1),检测波长:284 nm。结果 5-羟甲基糠醛在0.5~5μg·mL~(-1)范围内与峰面积呈良好的线性关系,r=1.000 0;加样回收率在93.3%~96.0%之间,RSD为0.93%;检测的3批混合糖电解质注射液中5-羟甲基糠醛的含量均低于10μg·mL~(-1)。结论该方法简便快速,准确可靠,重现性好,是测定混合糖电解质注射液中5-羟甲基糠醛含量的有效方法。
Objective To establish a high performance liquid chromatography (HPLC) method for the determination of 5-hydroxymethylfurfural in mixed sugar electrolyte injection. Methods Column: Welch Topsil C18 column (250 mm × 4.6 mm, 5 μm), column temperature 35 ℃, mobile phase 0.05 mol·L -1 monobasic potassium phosphate (90:10, V / V ), Flow rate: 0.8 mL · min ~ (-1), detection wavelength: 284 nm. Results 5-HMF showed a good linear relationship with the peak area in the range of 0.5-5 μg · mL -1, r = 1.000 0; the recoveries were between 93.3% and 96.0% with a RSD of 0.93 %. The contents of 5-hydroxymethylfurfural in the three batches of mixed sugar electrolyte were lower than 10μg · mL -1. Conclusion The method is simple and rapid, accurate and reliable, reproducible, and is an effective method for the determination of 5-hydroxymethylfurfural in mixed sugar electrolyte injection.