目的:建立欣力胶囊中黄芪甲苷的含量测定方法。方法:采用HPLC-ELSD法测定欣力胶囊中黄芪甲苷的含量,Agilent ZOBAX C18色谱柱(4.6mm×250mm,5μm),流动相为乙腈-水(32:68),流速为1.0mL·min^-1,柱温30℃,ELSD载气流速2.5L·min^-1。结果:黄芪甲苷在2.57~12.85μg范围内有良好的线性关系(r=0.9997),平均回收率(n=6)为98.2%。测定了3个批次欣力胶囊中黄芪甲苷的含量,其含量范围为0.29~0.30mg·粒^-1:该方法准确,重复性好,为欣力胶囊的质量控制提供了一种检测方法。
Objective:To establish an HPLC-ELSD method for the determination of astragaloside Ⅳ in Xinli cap-sules. Method: HPLC system consisting of an Agilent ZOBAX C18 column (4.6 mm×250 mm,5 μm)and a mixture of acetonitrile -water (32: 68) as the mobile phase was adopted and the flow rate was 1.0 mL·min^-1. The column temperature was set at 30℃. The flow rate of carrier gas was 2.5 L·min^-1.Results: Astragaloside IV showed good linearity (r=0.9997) in the range of 2.57-12.85μg. The average recovery (n=6) was 98.2%. Three batches of Xinli capsules were analyzed, and the content of astragaloside IV ranged from 0. 29 -0. 30 mg per capsule. Conclusion:This method possesses merits of good accuracy and reproducibility. The method can be used for the quality control of Xinli capsules and validate the manufacture technology of Xinli capsules.