To investigate the determination of seven active ingredients in Pudilan Anti-Inflammatory Tablets (蒲地蓝消炎片) by ultra-high performance liquid chromatography-mass spectrometry (UPLC-MS) method.

UPLC-MS was used to quantitatively analyze the seven main active ingredients in Pudilan Anti-Inflammatory Tablets. The differences in the contents of these active ingredients in the samples of Pudilan Anti-Inflammatory Tablets from different manufacturers were compared, aiming to provide scientific basis for the quality evaluation of Pudilan Anti-Inflammatory Tablets.

A certain amount of standard solution stock solution for each active ingredient was accurately measured and transferred to a 5 mL volumetric flask. According to the established chromatographic analysis conditions, the measurement results were obtained in the form of peak area. The peak area data was applied to the corresponding standard curve equations for calculation and recording. The results indicated that within the studied concentration range, there was a good linear correlation between the peak area of each active ingredient and its mass concentration. The relative standard deviation (RSD) values of precision in different active ingredients (chlorogenic acid, caffeic acid, chicory acid, purple violet spirit, baicalin, luteolin and baicalin in the same order of stability, reproducibility and recovery rate) were 0.99%, 0.31%, 1.20%, 1.47%, 1.31%, 1.29% and 0.33%, respectively. The RSD values of chromatographic peak area were all less than 1.46%, indicating that the instrument had good precision. After recording peak areas at 0, 3, 6, 12, 24, 48 h to evaluate stability, the RSD values of different active ingredients in Pudilan Anti-Inflammatory Tablets were 1.14%, 0.10%, 0.84%, 0.53%, 0.46%, 0.66% and 0.84%, respectively, indicating that the stability of the test solution was better within 24 hours. The peak area was measured to evaluate the repeatability, and the RSD values of different active ingredients in Pudilan Anti-Inflammatory Tablets were 1.28%, 1.75%, 1.43%, 1.04%, 2.39%, 0.93% and 2.61%, respectively, indicating that UPLC-MS/MS technology had good repeatability. The average RSD recovery rates of the active ingredients were 99.53% (RSD 2.38%), 100.63% (RSD 2.27%), 98.95% (RSD 2.29%), 101.58% (RSD 1.38%), 100.95% (RSD 2.25%), 97.26% (RSD 0.91%) and 98.56% (RSD 1.92%), respectively. There were significant differences in various effective ingredients in samples of Pudilan Anti-Inflammatory Tablets from different manufacturers.

UPLC-MS technology, with its excellent precision, stability and repeatability, can comprehensively reveal the quality status of Pudilan Anti-Inflammatory Tablets from different batches and manufacturers. This method has important positive effects on objectively evaluating drug quality, ensuring the drug quality and improving the clinical efficacy.