The qualitative and quantitative profiling for quality assessment of Yinxing Mihuan Oral Solution and the stability study on the focused flavonol glycosides.

Yinxing Mihuan Oral Solution (YMOS) has been widely applied for the treatment of coronary heart disease, angina pectoris, and cerebral ischemic disease in clinical practice. Nonetheless, the limited basic researches on quality analysis of YMOS remain a critical bottleneck that needs to be enhanced for better clinical applications. In this study, a total of 67 chemical components, including flavonoids, terpene lactones, nucleosides, etc., were tentatively characterized by ultra-high performance liquid chromatography tandem Q-Exactive Orbitrap high-resolution mass spectrometry, among which 34 compounds were further identified by comparison with reference substances. By adopting a methodologically validated method, we discovered that the quantitative estimate of multi-compounds in 22 batches of YMOS showed lot-to-lot consistency, and the additives in YMOS also met the corresponding regulations. Furthermore, five flavonol glycosides whose content presented a downward trend in the expired YMOS were focused. A systematic research on stability test focusing on the five targeted flavonol glycosides was performed under different temperatures and pH levels. It was found that ortho-diphenolic hydroxyl group on B-ring and the type of saccharide connected to 3-hydroxyl on C-ring play a pivotal role in the stability of the tested compounds. Subsequently, as the important compounds, ginkgolides A, B, and C in YMOS were simultaneously quantified with ultra performance liquid chromatography coupled with triple quadrupole mass spectrometry. In brief, this study performs a reliable chemical identification and provides a rapid and feasible method for the quality evaluation, which contributes to the in-depth investigation and safe application of YMOS for clinical uses.