Wang Xijun, Lv Haitao, Sun Hui, Jiang Xingang, Wu Zeming, Sun Wenjun, Wang Ping, Liu Lian, Bi Kaishun
Department of Pharmacognosy, Heilongjiang University of Chinese Medicine, Harbin, China.
J Sep Sci. 2008 Jan;31(1):9-15. doi: 10.1002/jssc.200700376.
A completely validated method based on HPLC coupled with photodiode array detector (HPLC-UV) was described for evaluating and controlling quality of Yin Chen Hao Tang extract (YCHTE). First, HPLC-UV fingerprint chromatogram of YCHTE was established for preliminarily elucidating amount and chromatographic trajectory of chemical constituents in YCHTE. Second, for the first time, five mainly bioactive constituents in YCHTE were simultaneously determined based on fingerprint chromatogram for furthermore controlling the quality of YCHTE quantitatively. The developed method was applied to analyze 12 batches of YCHTE samples which consisted of herbal drugs from different places of production, showed acceptable linearity, intraday (RSD <5%), interday precision (RSD <4.80%), and accuracy (RSD <2.80%). As a result, fingerprint chromatogram determined 15 representative general fingerprint peaks, and the fingerprint chromatogram resemblances are all better than 0.9996. The contents of five analytes in different batches of YCHTE samples do not indicate significant difference. So, it is concluded that the developed HPLC-UV method is a more fully validated and complete method for evaluating and controlling the quality of YCHTE.
描述了一种基于高效液相色谱-光电二极管阵列检测器（HPLC-UV）的完全验证的方法，用于评价和控制茵陈蒿汤提取物（YCHTE）的质量。首先，建立了YCHTE的HPLC-UV指纹图谱，初步阐明YCHTE中化学成分的含量和色谱轨迹。其次，首次基于指纹图谱同时测定了YCHTE中的五种主要生物活性成分，进一步定量控制YCHTE的质量。所建立的方法应用于分析12批由不同产地药材组成的YCHTE样品，线性良好，日内精密度（RSD<5%）、日间精密度（RSD<4.80%）和准确度（RSD<2.80%）均符合要求。结果，指纹图谱确定了15个代表性的通用指纹峰，指纹图谱相似度均优于0.9996。不同批次YCHTE样品中五种分析物的含量无显著差异。因此，得出结论，所建立的HPLC-UV方法是一种更全面验证和完整的评价和控制YCHTE质量的方法。
