高效液相色谱法测定黄杨宁片中环维黄杨星D的含量和含量均匀度

HPLC determination of content and uniformity of cyclovirobuxine D in Huangyangning tablets

目的:建立 HPLC 测定黄杨宁片中环维黄杨星 D 含量和含量均匀度的方法并进行方法学验证。方法:采取异氰酸苯酯柱前衍生化,HPLC 测定。色谱柱:Lichrospher C_(18)(5μm,4.6 mm×250 mm);流动相:甲醇-水(83:17);流速1 mL·min^(-1);检测波长:240 nm;柱温:30℃。结果:线性范围在0.08624～0.4312μg(r=0.9999);测得环维黄杨星 D 的平均回收率为97.92%,精密度,重复性,线性关系良好,结论:该方法可靠、准确、灵敏度高,为黄杨宁片剂的质量控制建立了良好的方法。

Objective：To establish an HPLC method with precolumn derivatization for determination the content and uniformity of cyclovirobuxine D in Huangyangning tablets. Method：The derivatization was carry out by using phenyl isocyanate as the derivating regent. The column was Lichrospher C18 （5 μm,4. 6 mm×250 mm）, the mobile phase consisted of methanol and water （83：17 ）, the flow rate was 1 mL · min^-1. The detection wavelength was set at 240 nm and the column temperature was 30 ℃. Results： The calibration curve was in the range of 0. 08624 μg to 0. 4312 μg （r = 0. 9999）. The average recovery of cyclovirobuxine D was 97.92%. Conclusion：The method is specific, sensitive, accurate and precise. It can be used for the quality control of cyciovirobuxine D in Huangyangning tablets.