Objective: To perform quantitative analysis of multi-target ingredients by single-marker(QAMS)method for Pudilan Xiaoyan tablets, and to validate the accuracy of the method. Methods: With solid-liquid ratio, methanol concentration and extraction time as investigation factors, comprehensive score for the contents of each component as evaluation indicators, the best extraction conditions were optimized by Box-Behnken response surface method. The relative correction factors (RCFs) of caftaric acid, cichoric acid, oroxylin A-7-O-β-D-glucuronide, wogonoside and baicalein were calculated with baicalin as internal reference. Meanwhile, the content of each component was determined by the external standard method (ESM), and the difference between the calculated and measured values were compared to verify the accuracy and feasibility of the method. An HPLC method was applied for quality assessment using an Agilent Poroshell 120 SB-C18 column (50 mm×2.1 mm, 2.7 μm). The mobile phase consisted of methanol-acetonitrile-0.1% phosphoric acid solution (gradient elution) at the flow rate of 0.3 mL·min-1. The column temperature was set at 30 ℃, and the detection wavelengths were 326 nm and 274 nm. The injection volume was 2 μL. Results: The optimal extraction conditions were determined to be 1∶125 for solid-liquid ratio, 60% for methanol concentration, and 1.5 h for extraction time. The linear relationship of the six chemical components was good (r≥0.999 6). The average recoveries were 98.1%-101.8% with RSDs of 0.34%-1.1%. RCFs of caftaric acid, cichoric acid, oroxylin A-7-O-β-D-glucuronide, wogonoside and baicalein to baicalin were 1.008, 0.919, 1.369, 0.857 and 0.642, respectively, and repeatability was good under different experimental conditions (RSD<3.0%). There was no significant difference between the quantitative results of the two methods. Conclusion: The established QAMS method, together with response surface methodology is accurate, reliable, simple and feasible, and can be used for quality control of Pudilan Xiaoyan tablets.
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