A simple, specific, sensitive, and precise high-performance liquid chromatography (HPLC) assay with UV detection has been developed for quantitative determination of fenozan acid in human blood plasma. Using this method, the pharmacokinetics of the new domestic preparation dibufelon (OOO Consortium-PIK, Russia) were investigated after a single peroral administration of an 800-mg dose in 12 healthy volunteers. It is established that the drug is rapidly absorbed from the GI tract into the systemic blood flow [C max ,178 ± 29 ng/mL; T max, 3.9 ± 0.5 h; AUC 0–∞, 1434 ± 269 (ng ∙ h)/mL; C max/AUC 0–∞, 0.135 ± 0.011 L/h], rather well retained in humans (MRT, 8.6 ± 0.8 h; T 1/2, 5.3 ± 0.8 h), and, despite a rapid total clearance (Cl t ,824 ± 167 L/h), penetrates well into organs and tissues (V Z , 5590 ± 1204 L).
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
Draft FSP “Dibufelon® capsules, 200 and 300 mg.”
VFS 42-1911-89.
FSP 42-0264-1103-01.
FSP 42-0372273802.
A. Z. Knizhnik, A. S. Berlyand, and A. V. Shukil(, Report “Bioavailability of Various Fenozan Drug Forms.”
A. A. Agafonov and V. K. Piotrovskii, Khim.-farm. Zh., 25(10), 16 – 19 (1991).
Author information
Authors and Affiliations
Additional information
Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 43, No. 11, pp. 54 – 56, November, 2009.
Rights and permissions
About this article
Cite this article
Kondratenko, S.N., Starodubtsev, A.K. & Belyakova, G.A. HPLC determination and pharmacokinetics of the new original domestic drug dibufelon®. Pharm Chem J 43, 641–643 (2009). https://doi.org/10.1007/s11094-010-0370-4
Received:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s11094-010-0370-4