RP-HPLC法测定施普睿达原料药中主药的含量

Content Determination of Main Component of Sprida Crude Drug by RP-HPLC

目的:建立反相高效液相色谱法(RP-HPLC)测定施普睿达原料药中主药含量的方法。方法:色谱柱为SunFireTMRPC18,流动相为磷酸盐缓冲溶液-乙腈(9∶1,V/V),流速为1mL·min-1,检测波长为220nm,进样量为10μL,柱温为25℃。结果:施普睿达检测浓度线性范围为0.004～0.5mg·mL-1(R2=0.9999),平均加样回收率为100.0%(n=9),RSD=0.23%(n=6)。结论:该方法系统适用性好、简便、准确可靠、重复性好,适合施普睿达的含量测定。

OBJECTIVE： To establish an RP-HPLC method for the determination of Sprida in its crude drug. METHODS： The separation was performed on SunFireTM RP C18 column with mobile phase consisted of phosphate buffer solution-acetonitrile （9： 1, V/V） and a flow rate of 1 mL·min^-1. The detection wavelength was set at 220 nm, injection volume 10 μL and column temperature 25 ℃. RESULTS： The linear range of Sprida was 0.004-0.5 mg·mL^-1（R^2=0.999 9） with an average recovery of 100.0% （n=9） and RSD was 0.23% （n=6）. CONCLUSION： The method is feasible, simple, accurate, reliable and reproducible for the content determination of Sprida.