HPLC fingerprint combined with chemometrics and multicomponent quantitative analysis for quality evaluation of Taohuajing granules

Abstract Taohuajing Granule (THJG) is a traditional Chinese medicine preparation for diabetic cardiomyopathy, yet its quality control remains unestablished. This study developed an HPLC-UV fingerprinting method combined with chemometrics and simultaneous quantification of six markers for comprehensive quality evaluation of THJG. Ten batches were analyzed, yielding 42 common peaks with similarity values exceeding 0.966. Hierarchical cluster analysis and principal component analysis classified the batches into two categories. Orthogonal partial least squares-discriminant analysis (OPLS-DA, Q 2 = 0.75) further validated this classification, and variable importance in projection analysis identified amygdalin, hydroxysafflor yellow A, and diosgenin as key differential markers. The quantitative method was fully validated (recoveries 97.2–98.9%, RSD <1.2%). This integrated fingerprint-chemometrics-quantification strategy provides a reliable tool for ensuring batch-to-batch consistency of THJG.