HPLC-ELSD测定注射用益气复脉(冻干)中钠离子含量

目的：建立一种用于测定注射用益气复脉（冻干）中钠离子含量的HPLC-ELSD方法。方法：采用Sepherisorb SCX（250 mm×4.6 mm，5 μm）色谱柱，以0.05 mol·L^-1醋酸铵（醋酸调节pH 4.8）-乙腈（50：50）为流动相，流速1.0 mL·min^-1，柱温30℃，蒸发光散射器漂移管温度80℃，气体压力241 kPa，增益15。结果：钠离子进样量在14.799～123.325 μg（r=0.999 5）范围内线性关系良好，平均回收率（n=9）为96.9%；样品中钠离子含量为19.05～20.67 mg·g^-1。结论：本法可为注射用益气复脉（冻干）生产中钠离子的控制提供实验方法。

Objective: To establish an HPLC-ELSD method for the determination of the content of sodium ion in lyophilized Yiqi Fumai for injection.Methods: The chromatographic separation was achieved on a Sepherisorb SCX(250 mm×4.6 mm,5 μm) column with mobile phase at a flow rate of 1.0 mL·min^-1.The mobile phase was water solution consisting of 0.05 mol·L^-1 ammonium acetate(pH was adjusted to 4.8 by acetic acid)-acetonitrile (50:50).The column temperature was 30℃.The drift tube temperature for the ELSD was set at 80℃ with the carrier gas pressure of 241 kPa and the detector gaining of 15.Results: Good linearity(r=0.999 5) was observed in the standard curves of sodium in the range of 14.799-123.325 μg,and the average recovery(n=9) of the method for sodium was 96.9%.The content of sodium ion in lyophilized Yiqi Fumai for injection was 19.05-20.67 mg·g^-1.Conclusion: The present process can provide an experimental method for the production quality control of sodium ion in lyophilized Yiqi Fumai for injection.