高效液相色谱法测定果糖氯化钠注射液与5-羟甲基糠醛的含量

Content Determination of Fructose and Sodium Chloride and 5-Hydroxymethylfurfural In Fructose and Sodium Chloride Injection by HPLC

目的建立测定果糖氯化钠注射液与5-羟甲基糠醛含量的高效液相色谱法。方法以磺酸型聚苯乙烯与二乙烯苯共聚体阳离子交换树脂H型为固定相,流动相为0.04mol/L磷酸溶液-0.1%枸橼酸溶液-甲醇(48∶43∶9),流速为0.4mL/min,检测波长为250nm,柱温为50℃。结果果糖进样量在1.67～50g/L范围内,5-羟甲基糠醛进样量在1.0～20.0mg/L范围内与峰面积呈良好的线性关系。结论该方法简便、灵敏、准确、重现性好,且果糖、氯化钠与5-羟甲基糠醛均分离良好,可用于该产品的质量控制。

Objective To establish a HPLC method for the content determination of fructose and sodium chloride and 5-hydroxymethylfurfural in Fructose and Sodium Chloride Injection. Methods The HPLC method was carried out on sulfonated polystyrene and diethylene benzene copolymer H type cation exchange resin. The mobile phase was 0. 04 mol / L H3PO4-0. 1% citric acid-methanol（48 ∶ 43 ∶ 9） and the flow rate was 0. 4 mL / min. The detection wavelength was set at 250 nm. Results The linear range of calibration curve was 1. 67-50 g / L for fructose and 1. 0 -20. 0 mg /L for 5-hydroxymethylfurfural. Conclusion The method is accurate,simple and rapid with good repeatability. Fructose, sodium chloride and5-hydroxymethylfurfural can be well separated. Therefore,the quality of Fructose and Sodium Chloride Injection can be effectively controlled.