Objective: To establish the UPLC fingerprint of Sijisanhuang pills and conduct a systemic, comprehensive quality evaluation of the drug using a chemical pattern recognition method. Methods: Ultra-high performance liquid chromatography instrument and Shimadzu Shim-pack gist C18(100 mm×2.1 mm, 2 μm) chromatographic column was employed, the separation was performed with the mobile phase consisting of acetonitrile and 0.1% trifluoroacetic acid elution, and the detection wavelength was set at 254 nm to establish the UPLC fingerprint of Sijisanhuang pills. Then, the further quality assessment was carried out by similarity evaluation, cluster analysis(CA), principal component analysis(PCA) and orthogonal partial least squares discriminant analysis(OPLS-DA). Results: The method had good repeatability and stability with RSD＜2%. Sixteen peaks were recognised as common peaks in the fingerprint. Eleven chromatographic peaks were identified with reference substances, they were geniposide, baicalin, wogonoside, berberine hydrochloride, baicalein, aloe emodin, rhein, wogonin, emodin, chrysophanol, physcion. The similarity values between samples from the same manufacturer were above 0.90. The similarity values between samples from different enterprises ranged from 0.70 to 0.80. Some difference was discovered between the batches of this drug by CA and PCA. Conclusion: The analysis method established in this study is accurate, reliable and simple. The drug quality of Sijisanhuang pills can be evaluated systematically and comprehensively using a fingerprint combined with chemical pattern recognition technique. What’s more, it is also suitable for the evaluation of the overall quality of Sijisanhuang pills.
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