HPLC determination, pharmacokinetics and relative bioavailability of levofloxacin produced by «OZONE», Russia
Abstract
A simple, specific, sensitive and reproducible good method for quantitative determination of Levofloxacin in plasma using HPLC with UV-spectrophotometric detection. With this technique the pharmacokinetics and relative bioavailability of domestic generic of levofloxacin in 18 healthy volunteers after a single oral dose of 500 mg. Found that the drug being tested, levofloxacin (OOO «Ozone», Russia) is bioequivalent to the reference drugs Tavanic® («Sanofi Winthrop Industry», France).
Keywords
левофлоксацин,
ВЭЖХ,
плазма крови,
фармакокинетика,
биодоступность,
биоэквивалентность,
воспроизведённые препараты,
дженерик,
levofloxacin,
HPLC,
blood plasma,
pharmacokinetics,
bioavailability,
bioequivalence,
generic drugs,
generic
Conflicts of Interest Disclosure:
The authors declares that there is no conflict of interest.
Article info:
Date submitted: 09.04.2020
All authors have read and approved the final manuscript.
Peer review info:
"Pharmacokinetics and Pharmacodynamics" thanks the anonymous reviewer(s) for their contribution to the peer review of this work.
Editorial comment:
In case of any discrepancies in a text or the differences in its layout between the pdf-version of an article and its html-version the priority is given to the pdf-version.
About the Authors
S. N. Kondratenko
First Moscow State Medical University I.M. Sechenov
Russian Federation
A. K. Starodubtcev
First Moscow State Medical University I.M. Sechenov
Russian Federation
E. A. Senik
First Moscow State Medical University I.M. Sechenov
Russian Federation
O. V. Dralova
First Moscow State Medical University I.M. Sechenov
Russian Federation
S. N. Kudinova
First Moscow State Medical University I.M. Sechenov
Russian Federation
References
1. Методические рекомендации по проведению качественных клинических исследований биоэквивалентности лекарственных препаратов «Оценка биоэквивалентности лекарственных средств». Москва, 2008. 32 с.
2. Flor S.C., Rogge M.C., Chow A.T. Bioequivalence of oral and intravenous ofloxacin after multiple-dose administration to healthy male volunteers. // Antimicrobial Agents and Chemotherapy. 1993. vol. 37, № 7. Р. 1468-1472.
3. Janssen-Ortho Inc. Product Monograph Levavin (levofloxacin). Antimicrobial Agent. Control №:105554. 2006. Р. 44-46.
4. Падейская Е.Н., Яковлев В.П. Антимикробные препараты группы фторхинолонов в клинической практике. Москва, Логата. 1998. 351 с.
5. Агафонов А.А., Пиотровский В.К. Программа M-IND оценки системных параметров фармакокинетики модельно-независимым методом статистических моментов. // Хим.-фарм. журнал. 1991. №10. С. 16 — 19.
For citations:
Kondratenko S.N.,
Starodubtcev A.K.,
Senik E.A.,
Dralova O.V.,
Kudinova S.N.
HPLC determination, pharmacokinetics and relative bioavailability of levofloxacin produced by «OZONE», Russia. Pharmacokinetics and Pharmacodynamics. 2013;(1):23-26.
(In Russ.)
Views:
745