Evaluation study of congelex laxative granules based on HPLC fingerprint, multi-component content determination, and chemometrics.

Congelex Laxative Granules is an in-house preparation of Hebei Provincial Hospital of Traditional Chinese Medicine. This study aims to establish the HPLC fingerprint of Congelex Laxative Granules and evaluate its quality using chemometric methods. The Agilent Eclipse Plus C18 column and a methanol-water gradient elution system were employed, with detection at 224 nm. The High-performance liquid chromatography (HPLC) analysis of 20 batches of samples successfully established a fingerprint with 17 common peaks and a similarity exceeding 0.95. Seven main active components, including salidroside, echinacoside, acteoside, specnuezhenide, wedelolactone, aurantio-obtusin, and chrysophanol, were quantitatively analyzed. Hierarchical Cluster Analysis (HCA), principal component analysis (PCA), and orthogonal partial least squares-discriminant analysis (OPLS-DA) were used to comprehensively evaluate sample quality. Results indicated that the 20 batches could be divided into two categories, with consistent results from PCA and HCA. The OPLS-DA model was stable and reliable, identifying salidroside, acteoside, and chrysophanol as key differential markers. The conclusion shows that the established fingerprint and content determination method provide an accurate and reliable tool for the quality control and comprehensive evaluation of Congelex Laxative Granules.