Quantitative determination of multi-class bioactive constituents for quality control of Yiqi Jiangzhi Granules

Abstract

Objective: To establish a reliable and sensitive method for evaluating quality of Yiqi Jiangzhi Granules (YQJZG).

Methods: Ultra performance liquid chromatography electrospray ionization tandem mass spectrometry (UPLC-ESI-MS/MS) was employed for simultaneous determination of eight marker components. Separation was performed on an AQUITY UPLC® HSS T3 column, the mobile phase consisted of acetonitrile as the organic phase and 0.1% (volume percentage) formic acid as the aqueous. Eight marker components, ginsenoside Rg1 (GRg1), ginsenoside Re (GRe), ginsenoside Rb1 (Gb1), typhaneoside (TEO), isorhamnetin-3-O-neohespeidoside (IN), hesperidin (HPD), aurantio-obtusin-6-O-β-D-glucoside (AG) and curcumin (CCM), were detected by multiple reaction monitoring (MRM) mode. The Chinese Pharmacopoeia (2020 edition) was regarded as the guidance document for this method validation.

Results: The method showed good linearity (R ² ≥ 0.9990). The relative standard deviation (RSD) values for the instrument precision, intermediate precision and repeatability were less than 2.91%, 2.88%, and 3.54%, respectively. The average recovery varied from 91.08% to 103.89%, with RSD below 3.81%. Sample solutions were found to be stable within 24 h at 4 °C (RSD < 2.85%). Eight marker components were successfully determined from three batches of YQJZG.

Conclusion: The proposed UPLC-ESI-MS/MS method was found to be simple, fast and sensitive, and can be used for the routine quality assessment of YQJZG. Simultaneously, this method may provide a new and powerful tool of quality control for other traditional Chinese medicine analogous formulae.

Keywords: UPLC-ESI-MS/MS; Yiqi Jiangzhi Granules; multiple reaction monitoring; quality control; traditional Chinese medicine.