Abstract:Objective To establish a high performance liquid chromatography (HPLC) fingerprint of Mailuotong Granules, and qualitatively analyze its chemical composition by triple quadrupole liquid chromatography-mass (LC-MS) system, and provide evidence for the quality evaluation of Mailuotong Granules. Methods Phenomenex Luna C18 (2) column (4.6 mm × 250 mm, 5 μm) was used. Acetonitrile-0.3% formic acid solution was used as mobile phase for gradient elution. The flow rate was 1.0 mL/min, column temperature was 25℃, and the detection wavelength was 270 nm. Ten batches of Mailuotong Granules were determined. The fingerprint of Mailuotong Granules was established with Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine (2004A edition). The common peaks were analyzed by positive and negative ion modes, and confirmed by the existing reference substances. Results The HPLC fingerprints of Mailuotong Granules were established. A total of 21 common peaks were identified and assigned to 8 herbs. The LC/MS system identified 19 common peaks, 7 of which were confirmed by comparison. Conclusion The method has good reproducibility and strong characteristics, which can provide a basis for the quality control of Mailuotong Granules and provide reference for the material basic research of other traditional Chinese medicine compounds.