Abstract:
OBJECTIVE To evaluate the quality of Zhenrongdan mixture by fingerprint combined with QAMS.
METHODS The quality evaluation method was established and validated with echinacoside as internal reference to determine the contents of other components (ferulic acid, salvianolic acid B, and icariin) according to the relative correction factor. The accuracy and feasibility of QAMS was evaluated by comparison on the results between the measured value and calculation value by external standard method and QAMS.
RESULTS A common pattern of characteristic fingerprint of zhenrong dan mixture by HPLC was established. Thirteen common peaks were identified, they accounted for 91% of the total peak area and four components were verified in five batches of Zhenrongdan mixture, good similarities with correlation coefficients >0.99 were found in the fingerprints. There was no significant difference between the quantitative results of the four ingredients in the five batches by external standard method and QAMS.
CONCLUSION The method of fingerprint combined with QAMS can be used for the quality control of multiple components determination and fingerprint chromatography for Zhenrongdan mixture.