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[摘要]
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。
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[Abstract]
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.
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