Study on Quality Control Method of Zhali Nusi Fang by UPLC Fingerprint and Multi-Components Quantitative Analysis

OBJECTIVE   To establish the UPLC-PDA fingerprint analysis and multi-components content determination methods of Zhali Nusi Fang.METHODS   A Waters ACQUITY UHPLC T₃ (2.1 mm × 100 mm, 1.7 μm) column was used with a gradient elution. The mobile phase was acetonitrile (A)-0.1% formic acid aqueous solution (B), flow rate was 0.4 mL/min, column temperature was 30 ℃, detection wavelength was 317 nm; nine chemical components were determined by UPLC-PDA.RESULTS   13 common peaks were found in the fingerprint of Zhali Nusi Fang and 9 peaks were identified by standard substances. The similarity of fingerprints of 10 batches was between 0.923 and 0.983. The linear relationship of 9 components was good in certain concentration range, and the r value was greater than 0.999 0. The results showed that the contents of cinnamic acid and gallic acid were high. The recoveries ranged from 98.82% to 102.91%, RSD was less than 2.52%. The samples were stable within 24 hours with good repeatability.CONCLUSION   The fingerprint analysis method and content determination method of Zhali Nusi Fang are established. The method is simple and repeatable, which can provide reference for further elucidation of the basic research of pharmacodynamic substances and quality control.