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目的:采用HPLC-ELSD法建立了测定果糖二磷酸钠胶囊含量的方法。方法:采用Symmetry Shield C18(250mm×4.6mm,5μm)色谱柱,流动相:甲醇-水(6∶94),流速:0.6mL·min-1,柱温:35℃。蒸发光散射检测器条件为:撞击器状态:关,漂移管温度:110℃,载气流速:2.0L·min-1。结果:果糖二磷酸钠的线性范围为0.5～5.0mg.mL-1,相关系数为0.9988。回收率(n=3)分别为98.9%,99.4%,99.8%;RSD为2.1%,1.3%,0.9%。结论:该方法操作简便,灵敏度高,快速、准确,适用于果糖二磷酸钠胶囊含量的质量控制。
OBJECTIVE: To establish a method for determination of sodium fructose diphosphate capsules by HPLC-ELSD. Methods: A Symmetry Shield C18 (250 mm × 4.6 mm, 5 μm) column was used. The mobile phase was methanol-water (6:94), the flow rate was 0.6 mL · min -1 and the column temperature was 35 ℃. Evaporative light scattering detector conditions were: striker status: OFF, drift tube temperature: 110 ° C, carrier gas flow rate: 2.0 L · min-1. Results: The linear range of fructose diphosphate was 0.5-5.0 mg.mL-1 with a correlation coefficient of 0.9988. The recoveries (n = 3) were 98.9%, 99.4% and 99.8%, respectively. The RSDs were 2.1%, 1.3% and 0.9%. Conclusion: The method is simple, sensitive, rapid, accurate and suitable for the quality control of sodium fructose diphosphate capsules.