【摘要】 目的:建立护肝片HPLC指纹图谱,为进一步提高护肝片的质量标准提供科学依据,并以此比较不同厂家产品质量的差异。方法:采用Agilent Zorbax SB-C18(4.6 mm×250 mm,5μm)色谱柱,流动相乙腈-水溶液梯度洗脱,检测波长250 nm,流速1.0 mL.min,柱温30℃。结果:确认了23个共有特征指纹峰,且方法学实验中相对保留时间及相对峰面积的RSD均<5%;不同来源的护肝片指纹图谱相似度均在0.9以上。结论:该方法准确可靠,可为护肝片的指纹图谱评价提供依据。更多还原

【Abstract】 Objective:To establish HPLC fingerprint of Hugan Tablet to improve its quality standard,and compare the quality of products from different companies using the new established method.Method: The separation was performed on Agilent Zorbax SB-C18(4.6 mm×250 mm,5 μm) chromatographic column with mobile phase consisted of acetonitrile-water(gradient elution) at a flow rate of 1.0 mL·min-1.Detecting wavelength was set at 250 nm and the column temperature was set at 30 ℃.Result: Twenty-three characteristic common peaks were confirmed.Relative standard deviations of relative retention time and relative peak area in the method verification were all less than 5%.The similarity of fingerprint of different sources of samples were all more than 0.9.Conclusion: The method is reliable,accurate and can be used as a method to assess the quality of Hugan Tablet.更多还原