Qualitative and quantitative analysis of major components of Renshen-Yangrong Pill by UPLC-LTQ/Orbitrap/MS and...

Renshen-Yangrong Pill (RYP) is a classical traditional Chinese medicine (TCM) preparation for the treatment of asthenic symptoms, while its multiple herbal compositions bring a wide variety of unclear chemical components which seriously hinder the effective quality control and clinical practice. The present study aimed to investigate the overall chemical profile of RYP by UPLC-LTQ/Orbitrap/MS, and further obtain the quantitative distributions of representing components in the preparations. A total of 132 components in RYP including flavonoids, triterpenoid saponins, phenylpropanoids, and monoterpenoid glycosides were identified or tentatively characterized by authentic compounds or accurate masses and fragmentation, in which 52 characteristic components were selected for further quantitation by UPLC-MS/MS. The assay was validated in terms of linearity, precision, repeatability, recovery and successfully applied for the quality control of 40 batches of RYP. Hesperidin and paeoniflorin were revealed as the most abundant constituents in RYP, and the samples of different origins and dosage forms were clearly classified based on hierarchical cluster analysis. This study provided a deep insight into the chemical profiling of RYP, as well as a new approach for determining the marker compounds, which laid a valuable foundation for further investigation of potential effective components and comprehensive quality control of RYP and related preparations.