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

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--neohespeidoside (IN), hesperidin (HPD), aurantio-obtusin-6----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 (  ≥ 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.