Study on Toddalia asiatica (L.) Lam. standard decoction based on HPLC characteristic chromatogram and content determination

Abstract Introduction The standard decoction of Toddalia asiatica (L.) Lam. (FLZX) possesses notable pharmacological properties including anti-inflammatory, analgesic, antimicrobial, and antiviral activities. However, its complex chemical composition necessitates the development of comprehensive quality assessment protocols to ensure consistent therapeutic efficacy. Objectives This study was designed to establish a reliable quality evaluation system for FLZX standard decoction through integrated analytical approaches, thereby facilitating quality control standardization. Methods Fifteen batches of FLZX standard decoctions were subjected to HPLC fingerprint analysis with similarity assessment. Multivariate chemometric analyses including cluster analysis (CA), principal component analysis (PCA), and orthogonal partial least squares discriminant analysis (OPLS-DA) were employed to evaluate origin-related variations. Characteristic peaks were identified and three major bioactive constituents were quantitatively determined. Results The established HPLC fingerprints contained eight characteristic peaks, with inter-batch similarities exceeding 0.900. Three bioactive markers (hesperidin, nitidine, and nitidine chloride) were unambiguously identified. Chemometric analysis revealed significant quality variations associated with geographical origin and harvesting period. Quantitative determination yielded concentration ranges of 0.850–3.829 mg g −1 for hesperidin, 3.612–10.251 mg g −1 for nitidine, and 0.087–0.335 mg g −1 for nitidine chloride, with corresponding transfer rates of 7.478–41.458%, 32.927–93.989%, and 3.235–17.392%, respectively. The extraction yields varied from 7.241% to 14.466%. Conclusion The combination of HPLC fingerprinting with chemometric pattern recognition establishes a robust quality assessment platform for FLZX standard decoction, providing both methodological and practical foundations for quality control in the production of related pharmaceutical preparations.