HPLC法测定抗骨质增生片中淫羊藿苷的含量

Content Determination of Icariin in Kangguzhi Zengsheng Tablet by HPLC

目的：建立测定抗骨质增生片中淫羊藿苷含量的方法,以期为完善该制剂的质量标准提供依据。方法：采用高效液相色谱法。色谱柱为Hypersil ODS2 C_（18）,流动相为乙腈-水（27∶73,V/V）,流速为1.0 ml/min,检测波长为270 nm,柱温为25℃,进样量为10μl。结果：淫羊藿苷检测质量浓度线性范围为3-60μg/ml（r=0.999 9）;定量限为11.2μg/ml,检测限为4.3μg/ml;精密度、稳定性、重复性试验的RSD〈2.0%;加样回收率为99.00%-100.67%（RSD=0.63%,n=6）。结论：该方法操作简便、结果准确、重复性好,可用于测定抗骨质增生片中淫羊藿苷的含量。

OBJECTIVE：To establish a method for the content determination of icariin in Kangguzhi zengsheng tablet,and provide a basis for improving the quality standard. METHODS：HPLC was performed on the column of Hypersil ODS2 C_（18） with mobile phase of acetonitrile- water（27 ∶ 73,V/V）at a flow rate of 1.0 ml/min,detection wavelength was 270 nm,column temperature was 25 ℃,and injection volume was 10 μl. RESULTS：The linear range of icariin was 3-60 μg/ml（r=0.999 9）;limit of quantitation was 11.2 μg/ml,limit of detection 4.3 μg/ml;RSDs of precision,stability and reproducibility tests were lower than 2.0%;recovery was 99.00%-100.67%（RSD=0.63%,n=6）. CONCLUSIONS：The method is simple,accurate and reproducible,and can be used for the content determination of icariin in Kangguzhi zengsheng tablet.