A validated method for the determination of doxofylline and its pharmacokinetic application in healthy volunteers.

Authors

Yonghua Yu, Danrui Liu, Hangyu Zhao, Menglong Dai, Yu Hu, Kaiwei Luo, Huina Zhang

Published in

Bioanalysis. Pages 1-9. Jul 30, 2025. Epub Jul 30, 2025.

Abstract

Current HPLC-based methods for doxofylline analysis lack speed and precision. A rapid, specific, and sensitive UPLC-MS/MS method was developed for the determination of doxofylline in this study.
This method was fully validated and doxophylline-d4 was used as an internal standard. A Kinetex-C18 column (EVO 100Å, 50 × 2.1 mm, 5 μm) was used for the separation procedure, with mobile phases consisting of 0.3% formic acid (A) and 90% acetonitrile solution with 0.3% formic acid (B). The total runtime of the gradient elution procedure was 2.6 minutes. The mass spectrometry analysis was carried out employing a multiple reaction monitoring model and using the transitions of m/z 267.000→181.000 for doxofylline and m/z 271.200→181.100 for the internal standard.
The linear range of detection for doxophylline was between 20.0 to 16,000 ng/mL. The intra-batch accuracy deviations of each concentration level ranged from -8.0% to 2.5%, while the intra-batch precisions ranged from 1.3% to 9.0%. And the inter-batch accuracy deviations were -5.8% ~0.8%, while the inter-batch precisions were 2.2% ~7.0%.
This method was applied to pharmacokinetic clinical trials of single oral administration of doxophylline tablets successfully.
www.clinicaltrials.gov identifier is CTR20240006 and CTR20233665.

PMID:
40735826
Bibliographic data and abstract were imported from PubMed on 30 Jul 2025.

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