Quantitative Evaluation of the Quality of Shiqi Waigan Granules Based on Fingerprinting and Multi‐Indicator Components With Multivariate Statistical Analysis

ABSTRACT 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.