PL EN


Preferencje help
Widoczny [Schowaj] Abstrakt
Liczba wyników
Tytuł artykułu

Method development and validation of an HPLC assay for the detection of hopantenic acid in human plasma and its application to a pharmacokinetic study on volunteers

Identyfikatory
Warianty tytułu
Języki publikacji
EN
Abstrakty
EN
A reliable and sensitive reversed-phase high performance liquid chromatography (RP-HPLC) with ultraviolet (UV) detection method was developed and validated for the quantification of hopantenic acid in human plasma. Hopantenic acid, with protocatechuic acid as the internal standard (IS), was extracted from plasma samples using a liquid-liquid extraction with methanol. A chromatographic separation was achieved on a Luna C18 column (4.6 mm × 150 mm, 5-μm particle size) and precolumn of the same sorbent (2.0 mm). An isocratic elution, at a flow rate of 1.0 mL min -1, was used with a mobile phase consisting of acetonitrile, water, and 0.03% trifluoroacetic acid. The UV detector was set to 205 nm. The elution times for hopantenic acid and IS were ∼4.3 and 5.4 min, respectively. The calibration curve of hopantenic acid was linear (r > 0.9994) over the range of 0.5–100 μg mL−1 in human plasma. The limit of detection and limit of quantification for hopantenic acid were 0.034 and 0.103 μg mL -1, respectively. The present method was successfully applied for the estimation of pharmacokinetic parameters of hopantenic acid following single oral administration of tablets containing 250 mg hopantenic acid to healthy volunteers. For hopantenic acid, the data showed a mean maximum plasma concentration (Cmax) of 2.32 μg mL, -1 with a time to reach peak plasma concentration (tmax) of 1.56 h.
Słowa kluczowe
Rocznik
Strony
403--414
Opis fizyczny
Bibliogr. 20 poz., rys., tab.
Twórcy
  • Saint-Petersburg Institute of Pharmacy 47/5, Piskarevsky pr. 195067 St. Petersburg Russia
autor
  • Saint-Petersburg Institute of Pharmacy 47/5, Piskarevsky pr. 195067 St. Petersburg Russia
autor
  • Saint-Petersburg Institute of Pharmacy 47/5, Piskarevsky pr. 195067 St. Petersburg Russia
autor
  • Saint-Petersburg Institute of Pharmacy 47/5, Piskarevsky pr. 195067 St. Petersburg Russia
  • Saint-Petersburg State Medical Academy Named After I.I. Mechnikov 47/33, Piskarevsky pr. 195067 St. Petersburg Russia
autor
  • Saint-Petersburg Institute of Pharmacy 47/5, Piskarevsky pr. 195067 St. Petersburg Russia
  • Saint-Petersburg State Medical Academy Named After I.I. Mechnikov 47/33, Piskarevsky pr. 195067 St. Petersburg Russia
autor
  • Saint-Petersburg Institute of Pharmacy 47/5, Piskarevsky pr. 195067 St. Petersburg Russia
  • Saint-Petersburg State Medical Academy Named After I.I. Mechnikov 47/33, Piskarevsky pr. 195067 St. Petersburg Russia
Bibliografia
  • [1] N. Ogawa, I. Nukina, Y. Hirose, M. Fukushima, and A. Mori, Jpn. J. Pharmacol., 37, 45–50 (1985)
  • [2] S. Nakamura, T. Takahashi, and Y. Sato, Vitamins (Japan), 45, 193–200 (1972)
  • [3] Y. Umeno, K. Nakai, E. Matsushima, and T.J. Marunaka, J. Chromatogr., 226, 333–339 (1981)
  • [4] K. Nakano, H. Ando, Y. Sugawara, M. Ohashi, and S. Harigaya, Drug Metab. Dispos., 14, 740–745 (1986)
  • [5] K. Banno, M. Matsuoka, S. Horimoto, and J. Kato, J. Chromatogr. Biomed. Appl., 525, 255–264 (1990)
  • [6] K. Banno, S. Horimoto, and M. Matsuoka, J. Chromatogr. Biomed. Appl., 564, 1–10 (1991)
  • [7] K. Banno, Methods Enzymol., 279, 213–219 (1997)
  • [8] R. Mittermayr, A. Kalman, M.J. Trisconi, and O. Heudi, J. Chromatogr. A 1032, 1–6 (2004)
  • [9] H. Iwase, Anal. Sci., 9, 149–151 (1993)
  • [10] O. Heudi and P. Fontannaz, J. Sep. Sci., 28, 669–672 (2005)
  • [11] M.V. Karlina, O.N. Pozharitskaya, A.N. Shikov, V.M. Kosman, M.N. Makarova, and V.G. Makarov, Chromatographia, 68, 949–954 (2008)
  • [12] O.N. Pozharitskaya, M.V. Karlina, A.N. Shikov, V.M. Kosman, M.N. Makarova, and V.G. Makarov, Phytomedicine, 16, 244–251 (2009)
  • [13] ICH, Q2A. Harmonised Tripartite Guideline, Text on Validation of Analytical Procedures, IFPMA. In: Proceedings of the International Conference on Harmonization, Geneva, 1994, pp. 1–5
  • [14] ICH, Q2B. Harmonised Tripartite Guideline, Validation of Analytical Procedure: Methodology, IFPMA. In: Proceedings of the International Conference on Harmonization, Geneva, 1996, pp. 1–8
  • [15] World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, and amended by the 52nd WMA General Assembly, Edinburgh, Scotland, 2000
  • [16] European Agency for the Evaluation of Medicinal Products, International Conference on Harmonisation. World Health Organization. Guideline for Good Clinical Practice. ICH Topic E6. WHO, Geneva, Switzerland, 2002
  • [17] M. Rowland and T.N. Tozer, Clinical Pharmacokinetics, Lippincott Williams & Wilkins, Philadelphia, 1995
  • [18] R. Ekinci and C. Kadakal, Acta Chromatogr., 15, 289–297 (2005)
  • [19] O. Heudi, T. Kilinic, and P. Fontannaz, J. Chromatogr. A, 1070, 49–56 (2005)
  • [20] S.S. Boiko, G.Iu. Vitskova, and V.P. Zherdev, Eksp. Klin. Farmakol., 60, 62–70 (1997)
Typ dokumentu
Bibliografia
Identyfikator YADDA
bwmeta1.element.baztech-10410db3-1697-4d51-8d79-efe4fd73a474
JavaScript jest wyłączony w Twojej przeglądarce internetowej. Włącz go, a następnie odśwież stronę, aby móc w pełni z niej korzystać.