QAMS-based Simultaneous determination and quality assessment of nucleoside analogs from Qi Zhi capsules.

Qi Zhi capsule (QZC) is approved by the State Drug Administration of China. QZC consists of nine crude drugs, including astragalus, leeches, ground beetles, curcuma zedoary, hawthorn, semen cassiae, rhizoma sparganii, polygonum multiflorum and peach kernel, of which leeches and ground beetles are Traditional Chinese Medicine (TCM) of animal origin. Nucleosides are animal substances with pharmacological effects that are easy to extract and quantify. Different nucleoside analogs in distinct animal-based formulations can be used to characterize animal-based medicines. However, the quality control of a single indicator does not reflect the overall quality of Chinese medicine. Here, we developed a method to simultaneously determine the nucleoside analogs uracil, xanthine, hypoxanthine, uridine, guanine, and uric acid in QZC using high-performance liquid chromatography. Hypoxanthine was used as an internal reference to determine relative correction factors for the other five components. The six components were determined in ten different batches of Qi Zhi capsules. There was no significant difference between the quantitative multicomponent analysis results of a single marker (QAMS) and the external standard method (ESM). The RSD of total nucleosides analogs of ten batches of samples was 7%. This method can be applied to simultaneously determine multiple active components in Qi Zhi capsules and other nucleoside analog drugs, enabling multi-indicator quality control.