Abstract
Tripterygium glycoside tablets (TGTs) are preparations extracted and purified from Tripterygium wilfordii Hook. F and are extensively utilized in the treatment of autoimmune diseases, such as rheumatoid arthritis (RA). However, variations in production processes among manufacturers can lead to challenges in quality control and clinical utilization of TGTs. A band-selective 2D (1)H-(13)C HSQC quantification method was applied for the determination of 13 active ingredients in TGTs. This method was validated following the guidelines of USP-NF 2022. The results demonstrated that the quantitative method exhibited excellent signal resolution, as well as sufficient accuracy, sensitivity, and stability. In addition, the (1)H NMR spectra of TGTs from three manufacturers underwent analysis using principal component analysis and orthogonal partial least-squares discriminant analysis. The results revealed significant differences among the TGTs from the three manufacturers, with manufacturer 2 and manufacturer 3 demonstrating superior product consistency compared to manufacturer 1. A quality evaluation system for TGTs was developed based on band-selective 2D (1)H-(13)C HSQC and (1)H NMR, encompassing both quality markers and fingerprinting. This system offers reliable approaches and insights for enhancing the quality control of natural products.