Objective  To establish an ultra-high performance liquid chromatography (UPLC) fingerprint for Shangke Dieda tablets, in order to better control product quality, and to determine the contents of 10 components including paeoniflorin, naringin, hesperidin, neohesperidin, lignan lactone, dehydrolignan lactone, aloe emodin, rhein, emodin, and emodin methyl ether simultaneously.

Methods  The chromatographic separation was performed on a Agilent InfinityLab Poroshell 120 SB-C₁₈ column (100 mm×4.6 mm, 2.7 μm). Acetonitrile-0.1% phosphoric acid aqueous solution was used as mobile phase for gradient elution, the flow rate was 1.0 mL/min, the column temperature was 30 ℃, the detection wavelength was 230 nm and the sample amount was 5 µL. The UPLC fingerprints of Shangke Dieda tablets were established, the similarity of 74 batches of Shangke Dieda tablets from 10 production enterprises were evaluated using traditional Chinese medicine chromatographic fingerprint similarity evaluation software, and the content of 10 components in Shangke Dieda tablets were determined.

Results  The results showed that a total of 10 common peaks were identified in the UPLC fingerprint of Shangke Dieda tablets, and the similarity of 74 batches of Shangke Dieda tablets were at the range of 0.85 to 0.99. The linear relationships of paeoniflorin, naringin, hesperidin, neohesperidin, lignan lactone, dehydrolignan lactone, aloe emodin, rhein, emodin, and emodin methyl ether were good, with r≥ 0.999  8. The average recovery rate was in the range of 97.0% to 105.1%, with RSD of 0.4% to 2.0% (n=6). The contents of these 10 components in 74 batches of Shangke Dieda tablets were as follows: 0.028-0.653, 0.042-0.931, 0.591-3.978, 0.021-0.593, 0-0.157, 0.009-0.231, 0.006-0.078, 0.022-0.593, 0.029-0.143 and 0.035-0.132 mg/tablet.

Conclusion   The UPLC fingerprint for Shangke Dieda tablets was established successfully, which can provide a basis for the quality evaluation of Shangke Dieda tablets. The method of simultaneously determining the content of 10 components is easy to operate and the results are accurate and reliable.

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