Quality Evaluation of Tanreqing Capsules Based on UPLC-CAD Fingerprint and of Multi-Component Content Determination

OBJECTIVE  To establish an integrated analytical method of fingerprints and simultaneous quantification of multiple components to provide a reference for optimizing their quality standards based on ultra performance liquid chromatography with electrospray detector(UPLC-CAD).

METHODS  A Hypersil GOLD(2.1 mm×100 mm, 3 µm) column was used with acetonitrile-0.1% formic acid aqueous solution as the mobile phase, gradient elution, the flow rate was 0.2 mL·min⁻¹, the column temperature was 30 ℃, the injection volume was 5 μL. The CAD atomizing chamber temperature was 35 ℃, the acquisition frequency was 5 Hz, and the filter was 5.0 s. The UPLC-CAD was used to establish the fingerprints of Tanreqing capsules. The quality of the 10 batches of Tanreqing capsules was evaluated by UPLC-CAD, combined with similarity evaluation and principal component analysis. At the same time, the seven active ingredients, forsythoside A, baicalin, phillyrin, cholic acid, ursodiol, chenodeoxycholic acid and deoxycholic acid, were used as indicators to establish their content determination methods.

RESULTS  The UPLC-CAD fingerprints of Tanreqing capsules identified 47 common characteristic peaks with similarity values above 0.970. Nine chemical components were identified by comparison with the reference substance. The seven components for quantitative analysis showed good linearity in their respective concentration ranges, with r values were 0.9991−0.999 8. The average recovery rates(n=6) were 96.94%−100.23%, with RSDs of 1.33%−2.62%. The contents of forsythoside A, baicalin, phillyrin, cholic acid, ursodiol, chenodeoxycholic acid and deoxycholic acid in the 10 batches of samples were 10.40−13.40、171.26−186.94、3.54−4.47、3.77−5.25、154.74−168.64、88.77−96.70、10.21−11.50 mg·g⁻¹, respectively. Principal component analysis showed that the first to ninth principal components were the main factors affecting the quality evaluation of Tanreqing capsules.

CONCLUSION  The established UPLC fingerprint and the simultaneous determination of the multi-indicator component content are accurate, simple, specific and reproducible, which can effectively evaluate the quality of Tanreqing capsules.