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目的:建立一种HPLC-ELSD方法检测得力生注射液中果糖、葡萄糖、蔗糖含量。方法:色谱柱:糖专用分析柱COSMO-SIL Sugar-D(250 mm×4.6 mm);流动相体系:10 mmol·L-1醋酸铵(A)-乙腈(B);流速:1 mL·min-1,梯度洗脱;检测器:蒸发光散射检测器;柱温:30℃;漂移管温度:85℃;干燥气流速:2.1 L·min-1。结果:在该条件下,果糖、葡萄糖、蔗糖都均能得到较好分离,其线性范围分别为1.024～63.98μg、1.032～64.52μg和0.4040～25.22μg;平均回收率(n=9)在95%～105%,RSD均小于5%。结论:该方法稳定可靠,操作简便,重复性好,适于测定得力生注射液中单糖及蔗糖的含量,可为得力生注射液的质量控制提供参考。
OBJECTIVE: To establish a HPLC-ELSD method for the determination of fructose, glucose and sucrose in Delisheng injection. Methods: Column: COSMO-SIL Sugar-D (250 mm × 4.6 mm); mobile phase system: 10 mmol·L-1 ammonium acetate (A) -1, gradient elution; detector: evaporative light scattering detector; column temperature: 30 ° C .; drift tube temperature: 85 ° C .; drying gas flow rate: 2.1 L · min-1. Results: Under these conditions, fructose, glucose and sucrose could all be separated well. The linear range was 1.024 ~ 63.98μg, 1.032 ~ 64.52μg and 0.4040 ~ 25.22μg, respectively. The average recoveries (n = 9) % ~ 105%, RSD less than 5%. Conclusion: The method is stable and reliable, easy to operate and reproducible. It is suitable for the determination of the content of monosaccharide and sucrose in Delisheng injection, which may provide a reference for the quality control of Delisheng injection.