Application of fingerprint combined with QAMS in quality evaluation of Shenxiong Yangxin Granule / 中草药

ABSTRACT

Objective: To establish a new method for the quality evaluation of Shenxiong Yangxin Granule by fingerprint and quantitative analysis of multi-components by single marker method (QAMS) and validate its accuracy and feasibility for the application in preparation. Methods: The quality evaluation method was established and validated with was selected as markers of ingredients to HPLC fingerprint was established with Shenxiong Yangxin Granule as study object and puerarin as internal reference to determine the contents of other components (ferulic acid, hesperidin, salvianolic acid B, ammonium glycyrrhizinate, and schisandrin) 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: Seventeen common peaks were identified in the HPLC characteristic fingerprint, six components were verified in ten batches of Shenxiong Yangxin Granule, good similarities with correlation coefficients higher than 0.99 were found in the fingerprints. There was no significant difference between the quantitative results of the six ingredients in the ten batches by external standard method and QAMS. Conclusion: The method of fingerprint combined with QAMS has been verified in Shenxiong Yangxin Granule, which could be used as a reference for the quality control of multiple components determination and fingerprint chromatography for Shenxiong Yangxin Granule in future.