Résumé
Objective To establish an HPLC fingerprint method of Sanlejiang Oral Liquid (SOL) and determine the contents of its main components, combining with clustering analysis for quality consistency evaluation of different batches, so as to provide a reference for the quality control. Methods Welchrom C18 (250 mm × 4.6 mm, 5 μm) column was adopted, the mobile phase consisted of 0.1% phosphoric acid water-methanol with gradient elution at the flow rate of 1.0 mL/min, and the detection wavelength was 270 nm, the column temperature was 25 ℃. HPLC fingerprint of SOL was established and determination method of gallic acid, gallocatechin, epicatechin, corilagin, and ellagic acid were studied methodologically. Results The fingerprint chromatography included 22 mutual peaks. At the same time, the 10 batches of SOL fingerprints were analyzed by similarity software, the similarity among the batches was more than 0.95. Based on the tetention time of master compounds, five components [gallic acid (peak 3), gallocatechin (peak 8), epicatechin (peak 15), corilagin (peak 16), and ellagic acid (peak 21)] were identified and quantified. The contents of gallic acid, gallocatechin, epicatechin, corilagin, and ellagic acid in 10 batches of Sanlejiang Oral Liquid were 5.743 2- 7.538 0, 0.492 9-0.847 1, 0.529 7-0.804 8, 0.937 5-1.756 5, and 0.352 7-0.554 5 mg/mL, respectively. Conclusion The established method is simple in good separation and reproducibility, achieving the qualitative and quantitative research for SOL, and thus can provide a reference for the standard and evaluation of quality of SOL.