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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。
OBJECTIVE: To establish HPLC fingerprints of Hugan tablet and provide a scientific basis for further improving the quality standard of Hugan tablet, and to compare the quality differences of different manufacturers. METHODS: The mobile phase was eluted with a mobile phase of acetonitrile-water using a Agilent Zorbax SB-C18 column (4.6 mm × 250 mm, 5 μm) with a detection wavelength of 250 nm and a flow rate of 1.0 mL · min at a column temperature of 30 ° C. Results: 23 common fingerprint peaks were identified, and the relative retention time (RSD) and relative peak area (RSD) were all less than 5% in the methodological experiments. The similarity of fingerprints of Hugan tablets from different sources were all above 0.9. Conclusion: The method is accurate and reliable, which can provide the basis for the fingerprint evaluation of Hugan tablet.