银黄颗粒的HPLC特征图谱分析

Analysis of HPLC specific chromatogram of Yinhuang granules

目的:建立银黄颗粒的RP-HPLC特征图谱分析方法,研究不同厂家银黄颗粒的质量。方法:色谱柱Aglient EclipseXDB-C18(4.6mm×150mm,5μm),流动相为乙腈-0.1%磷酸溶液,梯度洗脱,流速为1.0mL·min-1,检测波长为327nm。结果:银黄颗粒特征图谱共有12个共有峰,方法学考察结果良好,并对不同厂家的10批银黄颗粒进行了相似度比较,其中有8批样品相似度大于0.9,表明不同厂家产品之间具有一定的差异性。结论:采用HPLC特征图谱可实现全面和整体的评价,为有效提高银黄颗粒的质量控制提供参考。

Objective： To establish the specific chromatogram of Yinhuang granules by RP-HPLC in order to control its quality from different factories. Method： The method was carried out by an Agilent Eclipse XDB-C18 column（4.6 mm×150 mm,5 μm ） with a gradient mobile phase of a mixture of acetonitrile -0.1% phosphoric acid at a flow rate of 1.0 mL？min-1. The UV detection was performed at a wavelength of 327 nm. Result： The HPLC specific chromatogram of Yinhuang granules showed 12 common peaks.The methodological results were good. Ten batches of Yinhuang granules from different factories were compared.The similarity of eight batches of samples exceeded 0.9. Samples from different manufacturers showed the diversity. Conclusion：The specific chromatogram can realize the analysis of a formulas as a whole, which supplies references for improving the quality control of Yinhuang granules.