HPLC—ELSD法测定芪芍通络口服液黄芪甲苷含量研究

目的：建立芪芍通络口服液中黄芪甲苷的含量测定方法。方法：采用高效液相色谱一蒸发光散射检测（HPLC—ELSD）法定量分析芪芍通络口服液中黄芪甲苷的含量，色谱柱：Aglient Eclipse×DBC18（150mm×4．6mm，5μm），以乙腈一水（35：65）为流动相，流速1．0mL／min，柱温：25℃；蒸发光散射（ELSD）检测器，漂移管温度55℃，载气流速1．6L／min。进样量：10μL。结果：黄芪甲苷在0．274～5．48μg范围内呈良好的线性关系，r＝0．9997；平均回收率为98．8％，相对标准偏差（RSD）=1．2％，在常温下10h内稳定性较好。结论：HPLC—ELSD法简便快速、准确，重现性好，结果可靠；测得的该芪芍通络口服液每mL含黄芪以黄芪甲苷（C41H68O14）计为63．9μg；该黄芪甲苷含量测定法可作为控制芪芍通络口服液质量的方法。

Assaying of Astragaloside in Oral Liquid for Qi-shao Tong-luo by HPLC-ELSD

Objective： To establish an assay method of astragaloside in Oral Liquid for Qi-shao Tong-luo by HPLC-ELSD. Method： The content of astragaloside in Oral Liquid for Qi-shao Tong-luo was detected by HPLC- ELSD, and Agilent ZORBAX SB-C18 （ 150 mm× 4. 6mm, 5 μm） Column was used. The mobile phase was a mixture of acetonitrile-water （35： 65）, the flow rate was 1.0 mL/min, and the column temperature was 25 ℃. The temperature of drift tube for ELSD was 55℃ and the flow rate of air was 1.6 L/min. The sample size was 10μL. Result： A good linear relationship of Astragaloside was over the range of 0. 274 - 5.48 μg （r = 0. 999 7 ）, and the average recovery rate was 98.8%, RSD = 1.2%. The constancy was good within 10 hours under common temperature. Conclusion： The HPLC-ELSD method is convenient, sensitive and accurate. It can be a method for quality control of Oral Liquid for Qi-shao Tong-luo in production.