目的 建立HPLC-ELSD法测定注射用益气复脉（冻干）中葡甲胺的量。方法 色谱柱为Waters Sepherisorb SCX（250 mm×4.6 mm，5 μm），流动相为0.05 mol/L醋酸铵（醋酸调节pH=3.0）-乙腈（57：43），体积流量1.0 mL/min，柱温40℃，ELSD漂移管温度60℃，载气气体压力137.90 kPa，增益30。结果 葡甲胺进样量在4.351～29.005 μg呈良好的线性关系，r＝0.999 8，平均回收率（n＝9）为100.3%，RSD为2.27%。结论 本实验建立的方法简便、准确、可靠，可用于测定注射用益气复脉（冻干）的质量控制。
Objective To establish an HPLC-ELSD method for the determination of the content of meglumine in Yiqi Fumai Lyophilized Injection. Methods The chromatographic separation was carried on a Waters Sepherisorb SCX column (250 mm×4.6 mm, 5 μm) at 40℃ and the flow rate of 1.0 mL/min. The mobile phase was water solution consisting of 0.05 mol/L ammonium acetate (pH was adjusted to 3.0 by acetic acid)-acetonitrile (57:43). The drift tube temperature for the ELSD was set at 60℃ with the carrier gas pressure of 137.90 kPa and the detector gaining of 30. Results The calibration curve for meglumine revealed good linearity in the range of 4.351-29.005 μg (r=0.999 8).The average recovery (n=9) of the method was 100.3% with RSD 2.27%. Conclusion The method is simple, accurate and reliable. It could be used for the quality control of Yiqi Fumai Lyophilized Injection.