RESUMEN
OBJECTIVE To establish HPLC finger print of Leonurus japonicus granules，and to determine the contents of 4 index components such as leonurine hydrochloride ，ferulic acid ，rutin，hyperoside. METHODS The determination was performed on Inertsil TM ODS-3 column with mobile phase consisted of acetonitrile （A）-0.1％ formic acid solution （B）in the form of gradient elution；the flow rate was 1.0 mL/min，the detection wavelength was 280 nm，the column temperature was 25 ℃，and the sample size was 5 µL. Similarity Evaluation System of Chromatogram Fingerprint of TCM （2012 edition）was used for establishing the HPLC fingerprints of 10 batches of L. japonicus granules and analyzing their similarities. By comparing with HPLC fingerprints of reference substance ，the common peaks were identified. SPSS 25.0 and SIMCA 13.0 software were used for cluster analysis and principal component analysis ；the above HPLC method was used for the content determination of 4 index components in L. japonicus granules such as leonurine hydrochloride ，ferulic acid ，rutin，hyperoside. RESULTS HPLC fingerprints of 10 batches of L. japonicus granules were established ，and 16 common peaks were matched ，and 4 peaks identified were leonurine hydrochloride （peak 6），ferulic acid （peak 13），rutin（peak 14），hyperoside（peak 16）；the similarities of 10 batches of samples were all higher than 0.970. The 10 batches of samples could be divided into four categories by cluster analysis and principal component analysis；the classification results were consistent. The contents of leonurine hydrochloride ，ferulic acid ，rutin and hyperoside were 122.10-138.82 μ g/g，9.33-10.45 μ g/g，14.12-18.95 μ g/g，5.87-8.06 μ g/g，respectively. CONCLUSIONS Established HPLC fingerprint of L. japonicus granules and the method for the content determination of 4 index components are simple and easy to operate，and have high precision and good repeatability ，which provide reference for the quality evaluation of L. japonicus granules.