目的 建立HPLC-ELSD法測定注射用益氣復脈（凍干）中葡甲胺的量。方法 色譜柱為Waters Sepherisorb SCX（250 mm×4.6 mm，5 μm），流動相為0.05 mol/L醋酸銨（醋酸調(diào)節(jié)pH=3.0）-乙腈（57：43），體積流量1.0 mL/min，柱溫40℃，ELSD漂移管溫度60℃，載氣氣體壓力137.90 kPa，增益30。結(jié)果 葡甲胺進樣量在4.351～29.005 μg呈良好的線性關(guān)系，r＝0.999 8，平均回收率（n＝9）為100.3%，RSD為2.27%。結(jié)論 本實驗建立的方法簡便、準確、可靠，可用于測定注射用益氣復脈（凍干）的質(zhì)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.