Feng Lin, An Yaling, Mei Fang, Xia Tiyu, Jiang Huiling, Peng Lihua, Qiao Weilin, Guo De-an
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Quantitative Evaluation of the Quality of Shiqi Waigan Granules Based on Fingerprinting and Multi-Indicator Components With Multivariate Statistical Analysis
Shiqi Waigan Granules (SWG) are a widely used traditional Chinese medicine for treating common colds, yet a rapid and holistic quality-control protocol has been lacking. In this work, an HPLC fingerprint was built on an Agilent ZORBAX SB-C18 column (4.6 × 250 mm, 5 µm) with acetonitrile–0.1% phosphoric acid gradient elution, 330 nm detection, 40°C column temperature, and 0.6 mL/min flow. Eleven commercial batches were profiled, yielding nine consistent common peaks (similarity > 0.9). Eight of these peaks were unequivocally identified and quantified, all showing excellent linearity (r > 0.9999). Orthogonal partial least-squares discriminant analysis (OPLS-DA) with SIMCA software and variable-importance-in-projection (VIP) scoring highlighted four compounds whose levels differ most among batches and therefore drive product quality. Integrating fingerprinting, quantification, and multivariate statistics thus furnishes a reliable, efficient strategy for routine quality control of Shiqi Waigan Granules.
期刊介绍:
Biomedical Chromatography is devoted to the publication of original papers on the applications of chromatography and allied techniques in the biological and medical sciences. Research papers and review articles cover the methods and techniques relevant to the separation, identification and determination of substances in biochemistry, biotechnology, molecular biology, cell biology, clinical chemistry, pharmacology and related disciplines. These include the analysis of body fluids, cells and tissues, purification of biologically important compounds, pharmaco-kinetics and sequencing methods using HPLC, GC, HPLC-MS, TLC, paper chromatography, affinity chromatography, gel filtration, electrophoresis and related techniques.