目的 建立定坤丹的超高效液相色谱（ultra-high performance liquid chromatography，UPLC）指纹图谱，为其质量控制提供比较全面快速的评价方法。方法 采用Waters UPLC，Water Acquity UPLC? HSS T3色谱柱(2.1 mm × 100 mm，1.8 μm)，以0.1%甲酸水-0.1%甲酸甲醇溶液为流动相梯度洗脱，流速0.2 mL·min-1，检测波长280 nm，建立19批次定坤丹的UPLC指纹图谱。结果 建立了19批定坤丹样品的对照指纹图谱，确定了22个共有峰，经标准品化学对照及UPLC-MS确认共鉴别了其中8种成分，分别为没食子酸、5-羟甲基糠醛、芍药内酯苷、芍药苷、阿魏酸、甘草苷、黄芩苷和藁本内酯。19批供试品的指纹图谱全谱峰匹配的相似度均大于0.91，表明该复方总体质量较为稳定。结论 该指纹图谱方法科学、准确且简便，可以为定坤丹的内在质量控制提供科学依据。
Objective To establish the method for ultra-high performance liquid chromatography (UPLC) fingerprints of Dingkun Dan (DKD) and to be used as a comprehensive and efficient method of quality evaluation.Methods UPLC instrument was employed to establish the UPLC fingerprint of 19 batches of DKD. The separation was performed with the mobile phase consisting of 0.1% formic acid methanol and 0.1% formic acid aqueous solution with Acquity UPLC? HSS T3 chromatographic column (2.1 mm × 100 mm,1.8 μm) at flow rate of 0.2 mL·min-1, and the detection wavelength was set at 280 nm.Results In this research, 22 peaks were recognized as common peaks in the fingerprints. Among them, 8 peaks were identified by using standard references, including gallic acid, 5-hydroxymethyl-2-furaldehyde, albiflorin, paeoniflorin, ferulic acid, liquiritin, baicalin and ligustilide. The similarity values of the different lots of drugs were all above 0.91, indicating the relatively stable quality of the drugs.Conclusion The UPLC analysis method established in this study is scientific, accurate, reliable, and simple, and it is suitable for quality control of DKD.