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

IF 3.1 3区医学 Q2 CHEMISTRY, ANALYTICAL

Journal of pharmaceutical and biomedical analysis Pub Date : 2024-12-13 DOI:10.1016/j.jpba.2024.116636

Chengjialu Qian, Shizhao Wang, Hongyan Chen

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引用次数: 0

Abstract

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.

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来源期刊

Journal of pharmaceutical and biomedical analysis 医学-分析化学

CiteScore

6.70

自引率

5.90%

发文量

588

审稿时长

37 days

期刊介绍： This journal is an international medium directed towards the needs of academic, clinical, government and industrial analysis by publishing original research reports and critical reviews on pharmaceutical and biomedical analysis. It covers the interdisciplinary aspects of analysis in the pharmaceutical, biomedical and clinical sciences, including developments in analytical methodology, instrumentation, computation and interpretation. Submissions on novel applications focusing on drug purity and stability studies, pharmacokinetics, therapeutic monitoring, metabolic profiling; drug-related aspects of analytical biochemistry and forensic toxicology; quality assurance in the pharmaceutical industry are also welcome. Studies from areas of well established and poorly selective methods, such as UV-VIS spectrophotometry (including derivative and multi-wavelength measurements), basic electroanalytical (potentiometric, polarographic and voltammetric) methods, fluorimetry, flow-injection analysis, etc. are accepted for publication in exceptional cases only, if a unique and substantial advantage over presently known systems is demonstrated. The same applies to the assay of simple drug formulations by any kind of methods and the determination of drugs in biological samples based merely on spiked samples. Drug purity/stability studies should contain information on the structure elucidation of the impurities/degradants.