Quality assessment of Shuangyu Granules based on simultaneous determination by HPLC fingerprint and multi-components / 中草药

ABSTRACT

Objective: To establish an HPLC fingerprint chromatography and determine seven compounds of multi-components in Shuangyu Granules (SG). Methods: The Kromasil C18 (250 mm × 4.6 mm, 3.5 μm) column was used with a mobile phase of acetonitrile-0.05% trifluoroacetic acid gradient elution. The flow rate was 0.8 mL/min, the column temperature was 30℃, and the detection wavelengths were 230 and 327 nm. The common peaks were identified by Q-TOF/MS. Results: The fingerprint chromatography included 17 mutual peaks, and the similarity was more than 0.95. Fourteen common peaks had been identified by LC-Q-TOF/MS, seven of which were unequivocally identified via comparing the retention times and mass spectra data with those of the standard compounds. Then the seven marker components were quantified. The developed quantitative method was validated in terms of accuracy (the recoveries ranged from 97.8% to 101.8% with RSDs less than 2%). Conclusion: The method is rapid, simple, and accurate and can be used for the quality control of SG.