关键词: font-size:medium, ">葡萄糖酸钙锌口服溶液； 5-羟甲基糠醛； 高效液相色谱法； 含量测定

Abstract: Objective： To establish a general HPLC method of 5-hydroxymethyl furfural in Calcium gluconate oral solution to provide information for drug quality control and clinical medication. Methods： The separation was performed on a Agela Venus MP C18（250 mm×4.6 mm， 5 μm) column with gradient elution of 2.4mmol·L-1 citric acid solution-methanol at the flow rate of 1.0 mL·min-1.The detection wavelength was 284 nm. The column temperature was 30 ℃ and the injection volume was 20 μL. Results：Under experimental conditions， there is a good linear relationship within the range of 0.5 μg·mL-1 to 15 μg·mL-1， with a linear correlation coefficient of 1.000 0. The detection limit of the method is 18 ng·mL-1， the quantitative limit is 60 ng·mL-1， and the recovery rate of sample spiking is 100.14%~101.79%. Conclusion：It is suggested to raise the determination of 5-hydroxymethyl furfural in the quality standard of Calcium gluconate oral solution to provide reference for the quality control of Calcium gluconate oral solution and the improvement of production process.

Key words: font-size:medium, ">Calcium gluconate oral solution； 5-hydroxymethyl furfural； High performance liquid chromatography method； Determination and evaluation