Abstract

A method was established to analyze the fingerprint of Dazhu Hongjingtian capsule by HPLC-DAD.The separation was performed on Agilent Eclipse Plus-C₁₈(4.6 mm×250 mm, 5 μm) with methanol-0.1% formic acid solution as the mobile phase for gradient elution at a flow rate of 1.0 mL•min⁻¹; the detection wavelength was set at 276 nm and column temperature was set at 35 ℃. A total of 10 batches of samples were detected by the above method, and based on their fingerprint by using Similarity Evaluation System for Chromatographic Fingerprint of TCM (2004A), 21 common chromatographic peaks were determined and after the individual common peak whose peak area was greater than 50% of the total peak area was deducted, the similarity results of these samples were analyzed and compared. The results showed that the similarity of 10 batches of samples was all higher than 0.940. HPLC/Q-TOF-MS was used to identify the common chromatographic peaks in the fingerprint and determine the molecular formulas of twenty-one common chromatographic peaks. The structures of 11 fingerprint peaks were tentatively identified based on the control products and mass spectrometry information. This was the first time to establish fingerprint by using HPLC method and identify fingerprint peaks by using HPLC/Q-TOF-MS. This method has good precision, stability and repeatability, and could provide basis for quality evaluation of Dazhu Hongjingtian capsule.

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