HPLC法同时测定参芪扶正注射液中6种成分的含量

Simultaneous Determination of Six Components in Shenqi Fuzheng Injection by HPLC

目的：建立同时测定参芪扶正注射液中黄芪皂苷Ⅰ、Ⅱ、Ⅲ、Ⅳ和党参炔苷、芒柄花素含量的方法。方法：采用高效液相色谱法。色谱柱为Ultimate XB-C_（18）,检测器为蒸发光散射检测器,流动相为乙腈-0.5%甲酸（梯度洗脱）,流速为1.2 ml/min,柱温为30℃,进样量为10μl。结果：黄芪皂苷Ⅰ、Ⅱ、Ⅲ、Ⅳ、党参炔苷和芒柄花素检测进样量线性范围分别为0.62-5.67μg（r=0.999 6）、0.78-6.31μg（r=0.999 6）、0.36-3.48μg（r=0.999 7）、0.81-6.72μg（r=0.999 5）、0.82-7.03μg（r=0.999 8）、0.58-6.62μg（r=0.999 7）;定量限分别为1.21、0.15、0.12、0.03、0.12、0.17μg/ml;检测限分别为0.35、0.35、0.04、0.01、0.03、0.04μg/ml;精密度、稳定性、重复性试验的RSD〈2%;加样回收率分别为95.1%-101.1%（RSD=2.0%,n=9）、95.2%-100.7%（RSD=1.9%,n=9）、95.8%-100.2%（RSD=1.4%,n=9）、96.2%-100.6%（RSD=1.7%,n=9）、96.6%-101.2%（RSD=1.4%,n=9）、95.9%-99.5%（RSD=1.2%,n=9）。结论：该方法操作简便、结果准确,可用于同时测定参芪扶正注射液中黄芪皂苷Ⅰ、Ⅱ、Ⅲ、Ⅳ、党参炔苷和芒柄花素的含量。

OBJECTIVE：To establish a method for the contents determination of astragalosidesⅠ,Ⅱ,Ⅲ,Ⅳ,lobetyolin and formononetin in Shenqi fuzheng injection. METHODS：HPLC was performed. The detector was evaporative light scattering detector,column was Ultimate XB-C_（18） with mobile phase of acetonitrile-0.5% formic acid（gradient elution）at a flow rate of 1.2 ml/min,column temperature was 30 ℃,and injection volume was 10 μl. RESULTS：The linear range was 0.62-5.67 μg for astragalosidesⅠ（r=0.999 6）,0.78-6.31 μg for astragalosidesⅡ（r=0.999 6）,0.36-3.48 μg for astragalosidesⅢ（r=0.999 7）,0.81-6.72 μg for astragalosides Ⅳ（r=0.999 5）,0.82-7.03 μg for lobetyolin（r=0.999 8）and 0.58-6.62 μg（r=0.999 7）formononetin;limit of quantitation was 1.21,0.15,0.12,0.03,0.12,0.17 μg/ml;limit of detection was 0.35,0.35,0.04,0.01,0.03,0.04 μg/ml;RSDs of precision,stability and reproducibility tests were lower than 2%;recoveries were 95.1%-101.1%（RSD=2.0%,n=9）,95.2%-100.7%（RSD=1.9%,n=9）,95.8%-100.2%（RSD=1.4%,n=9）,96.2%-100.6%（RSD=1.7%,n=9）,96.6%-101.2%（RSD=1.4%,n=9） and 95.9%-99.5%（RSD=1.2%,n=9）,respectively. CONCLUSIONS：The method is simple and accurate,and can be used for the simultaneous determination of astragalosidesⅠ,Ⅱ,Ⅲ,Ⅳ,lobetyolin and formononetin in Shenqi fuzheng injection.