HPLC-ELSD法测定复方甘露醇注射液中甘露醇及葡萄糖的含量

Determination of Mannitol and Glucose in Compound Mannitol Injection by HPLC-ELSD

目的:建立同时测定复方甘露醇注射液中甘露醇及葡萄糖的含量方法。方法:应用高效液相色谱-蒸发光散射检测器,氨基硅烷键合硅胶为填充剂的色谱柱(5μm,250mm×4.6mm),乙腈-水(85∶15)溶液为流动相,流速为1.4mL·min^(-1),漂移管温度为100℃,载气(空气)流速为2.74mL·min^(-1)。结果:葡萄糖在0.6-1.4mg·mL^(-1)范围内线性关系良好(r=0.9980,n=6),回收率为100.8%(RSD 为0.9%,n=9)。甘露醇在0.3-9.0mg·mL^(-1)范围内线性关系良好(r=0.9992,n=6),回收率为100.1%(RSD 为1.0%,n=9)。结论:该方法简便准确,重现性好,可作为本产品的质量控制方法。

Objective:To establish a method to determine the content of mannitol and glucose in compound manni- tol injection.Method:ELSD was used to determine mannitol and glucose.The separation was performed on NH_2 col- umn(5μm,250mm×4.6mm)with acetonitrile-water(85:15)as mobile phase.The flow rate was 1.4mL· min^(-1).The temperature of drift tube for measurement was 100 ℃ and the flow rate of air was 2.74mL·min^(-1). Results:The linear range of glucose was 0.6-1.4mg·mL^(-1)(r=0.9980,n=6),the average recovery was 100.8%(RSD=0.6%,n=9).The linear range of mannitol was 0.3-9.0mg·mL^(-1)(r=0.9992,n=6),the av- erage recovery was 100.1%(RSD=1.0%,n=9).Conclusion:This method is simple,accurate and reproducible, The method can be used for the quality control of mannitol and glucose.