HPLC法测定葡萄糖氯化钠注射液中葡萄糖的含量

Determination of the Content of Glucose in Glucose/Sodium Chloride Injection by HPLC

目的:建立以高效液相色谱法测定葡萄糖氯化钠注射液中葡萄糖含量的方法。方法:色谱柱为Waters Sugar PakⅠ,流动相为水,柱温为80℃,示差折光检测器设定温度为40℃,进样量为20μL。结果:葡萄糖检测浓度的线性范围为0.05～2.50mg·mL-1(r=0.9999),最低检测限为24ng,平均回收率为99.80%～99.90%,RSD=0.21%。结论:本方法操作简便快速、灵敏度高、结果准确,可用于该制剂中葡萄糖的含量测定。

OBJECTIVE： To establish an HPLC method for the determination of the content of glucose in Glucose/Sodium Chloride injection. METHODS： The determination was performed on Waters Sugar Pak I column with column temperature set at 80 ℃, water as mobile phase and injection volume of 20 uL. The cell temperature of RID detector was set at 40 ℃. RESULTS： The linear range of glucose was 0.05-2.50 mg.mL^-1 （r=0.999 9） with the lowest detection limit of 24 ng. The average recovery ranged from 99.80% to 99.90% （RSD=0.21%）. CONCLUSION： The method is simple, rapid, accurate, sensitive and reliable in operation, and it is applicable for determination of glucose in Glucose/Sodium Chloride injection.