Shi Yi-Kai, Cui Fang, Hu Fang-Di, Bi Ying-Yan, Ma Yu-Feng, Feng Shi-Lan
School of Pharmacy, Lanzhou University, Lanzhou 730000, China.
Gansu Province Key Laboratory of Preclinical Study for New Drugs of Gansu Province, Lanzhou 730000, China.
J Pharm Anal. 2011 Feb;1(1):20-25. doi: 10.1016/S2095-1779(11)70004-1. Epub 2012 Jan 30.
A simple and accurate high-performance liquid chromatography (HPLC) coupled with diode array detector (DAD) and evaporative light scattering detector (ELSD) was established for the determination of six bioactive compounds in Zhenqi Fuzheng preparation (ZFP). The monitoring wavelengths were 254, 275 and 328 nm. Under the optimum conditions, good separation was achieved, and the assay was fully validated in respect of precision, repeatability and accuracy. The proposed method was successfully applied to quantify the six ingredients in 31 batches of ZFP samples and evaluate the variation by hierarchical cluster analysis (HCA), which demonstrated significant variations on the content of these compounds in the samples from different manufacturers with different preparation procedures. The developed HPLC method can be used as a valid analytical method to evaluate the intrinsic quality of this preparation.
建立了一种简单准确的高效液相色谱法(HPLC),该方法结合二极管阵列检测器(DAD)和蒸发光散射检测器(ELSD),用于测定贞芪扶正制剂(ZFP)中的六种生物活性成分。监测波长为254、275和328 nm。在最佳条件下,实现了良好的分离,并且该测定法在精密度、重复性和准确性方面得到了充分验证。所提出的方法成功应用于定量31批ZFP样品中的六种成分,并通过层次聚类分析(HCA)评估其差异,结果表明不同厂家采用不同制备工艺的样品中这些化合物的含量存在显著差异。所建立的HPLC方法可作为评估该制剂内在质量的有效分析方法。