Objective To evaluate the quality of Fagopyri Dibotryis Rhizoma Tablets (FDRT) produced by different companies. Methods A total of 18 batches of FDRT produced by company A and 20 batches of FDRT produced by company B were collected, respectively. The fingerprints of 38 batches FDRT were determined using HPLC, the common peaks were assigned and the constituents of these peaks were identified by quadrupole time-of-flight mass spectrometry (Q-TOF-MS/MS). Using quantitative common peak areas as variables, pattern recognition analysis of the fingerprint was conducted using hierarchical cluster analysis (HCA), principal component analysis (PCA), and orthogonal partial least squares discriminant analysis (OPLS-DA). The content of the nine constituents confirmed by comparison with reference substances and have good separation in samples were determined. Results There were 33 common peaks in the fingerprint of 38 batches of FDRT, and a total of 53 constituents were identified by Q-TOF-MS/MS, including 21 tannins, 12 phenolics, seven flavonoids, seven phenylpropanoid glycosides, two amino acids, two organic acids, one alkaloid, and one terpenoid, among them, three phenolics (gallic acid, protocatechuic acid, and protocatechualdehyde), five tannins (procyanidin B1, B2, B3, C1, C2), four flavonoids (catechin, epicatechin, epicatechin gallate, and rutin) were confirmed by reference substance. The separation degree of nine constituents except for procyanidin C2, B2, and rutin was relatively good. The average content of these nine constituents in FDRT produced by company B was significantly higher than that in FDRT produced by company A (P < 0.01). The results of HCA, PCA, and OPLS-DA were consistent, clearly distinguished the FDRT produced by company A and company B into two categories. The constituents corresponding to common peaks 30, 29, 16, 17, 2, 21, 10, 11, 18, 20, and 27, such as procyanidin C2, B2, C1, B1, B3, gallic acid, epicatechin, etc., are the marker constituents responsible for the quality differences in FDRT produced by two enterprises. Conclusion There is a significant quality difference in FDRT produced by two companies.

Fagopyri Dibotryis Rhizoma Tablets  /  quality evaluation  /  HPLC  /  fingerprint  /  Q-TOF-MS/MS  /  pattern recognition  /  hierarchical cluster analysis  /  principal component analysis  /  orthogonal partial least squares-discriminant analysis  /  tannins  /  phenolics  /  flavonoids  /  phenylpropanoid glycosides  /  amino acids  /  organic acids  /  alkaloids  /  terpenoids  /  gallic acid  /  protocatechuic acid  /  protocatechuic aldehyde  /  procyanidins  /  catechin  /  epicatechin  /  epicatechin gallate  /  rutin