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Development and validation of a rapid selective high-throughput LC-MS/MS method for the determination of triclabendazole sulfoxide concentrations in sheep plasma and its use in bioequivalence studies

Identyfikatory
Warianty tytułu
Języki publikacji
EN
Abstrakty
EN
Triclabendazole is one of the main drugs used to treat liver fluke in livestock. A rapid LC-MS/MS method was developed and validated to determine ovine plasma levels of triclabendazole sulfoxide. A Gemini NX-C18 column was used to achieve analytical separation, with gradient elution of a mobile phase composed of 0.1% formic acid in acetonitril and 0.1% formic acid in water at flow rate of 0.6 mL/min. MRM with positive ESI ionization was used for the detection of triclabendazole sulfoxide (m/z 360.10 from m/z 376.97). Fenbendazole was used as internal standard. Plasma protein precipitation with acetonitrile was used for sample processing. The method was validated with regards to selectivity, linearity (r > 0.9939), within run and between run precision (CV < 8.9%) and accuracy (bias < 8.9%) over the concentration range 1–100 µg/mL plasma. The method developed is simple, selective and can be applied in bioequivalence and bioavailability studies.
Słowa kluczowe
Rocznik
Strony
170--178
Opis fizyczny
Bibliogr. 19 poz., rys., tab.
Twórcy
  • Department of Pharmaceutical Technology and Biopharmaceutics, Faculty of Pharmacy, University of Medicine and Pharmacy “Iuliu Hatieganu”, 8 Victor Babes st., RO-400012, Cluj-Napoca, Romania
  • Clinical and Analytical Research Center, Vim Spectrum SRL, 409 Sighisoarei st., RO-547367, TarguMures, Corunca, Romania
  • Center for Advanced Medical and Pharmaceutical Research, University of Medicine and Pharmacy, Gheorghe Marinescu st. 38, RO-540142, Targu-Mures, Romania
autor
  • Clinical and Analytical Research Center, Vim Spectrum SRL, 409 Sighisoarei st., RO-547367, TarguMures, Corunca, Romania
  • Clinical and Analytical Research Center, Vim Spectrum SRL, 409 Sighisoarei st., RO-547367, TarguMures, Corunca, Romania
  • Department of Pharmaceutical Technology and Biopharmaceutics, Faculty of Pharmacy, University of Medicine and Pharmacy “Iuliu Hatieganu”, 8 Victor Babes st., RO-400012, Cluj-Napoca, Romania
Bibliografia
  • 1. Tsega, M.; Dereso, S.; Getu, A. A review on ruminant fasciolosis. O. A. Lib. J. 2015, 2, e165.
  • 2. Report of the WHO Informal Meeting on Use of Triclabendazole in Fascioliasis Control, WHO Headquarters: Geneva, Switzerland, 17–18 October 2006.
  • 3. Mas-Coma, S.; Bargues, M. D.; Valero, M. A. Human fascioliasis infection sources, their diversity, incidence factors, analytical methods and prevention measures. Parasitology 2018, 145, 1665–99.
  • 4. Maco, V.; Marcos, L.; Delgado, J.; Herrera, J.; Nestares, J.; Terashima, A. et al. Effcacy and tolerability of two single-day regimens of triclabendazole for fascioliasis in Peruvian children. Rev. Soc. Bras. Med. Trop. 2015, 48(4), 445–53.
  • 5. Cwiklinski, K.; O’Neill, S. M.; Donnelly, S.; Dalton, J. P. A prospective view of animal and human Fasciolosis. Parasite Immunol. 2016, 38(9), 558–68.
  • 6. Barrera, B.; Otero, J. A.; Egido, E.; Prieto, J. G.; Seelig, A.; Alvarez, A. I. et al. The anthelmintic triclabendazole and its metabolites inhibit theMembrane transporter ABCG2/BCRP Antimicrob. Agents Chemother. 2012, 56(7), 3535–43.
  • 7. Kelley, J. M.; Elliott, T. P.; Beddoe, T.; Anderson, G.; Skuce, P.; Spithill, T. W. Current threat of triclabendazole resistance in Fasciola hepatica. Trends Parasitol. 2016, 32(6), 458–69.
  • 8. Halferty, L.; Brennan, G. P.; Trudgett, A.; Hoey, L.; Fairweather, I. The relative activity of triclabendazole metabolites against the liver fluke, Fasciola hepatica. Vet. Parasitol. 2009, 159, 126–38.
  • 9. Joint FAO/WHO Expert Committee on Food Additives. Meeting, Food and Agriculture Organization of the United Nations, p 72.
  • 10. Bull, M. S.; Shume, G. R. Simultaneous determination of fenbendazole, its sulfoxide and sulphone metabolites with the corresponding metabolites of triclabendazole in the plasma of sheep and cattle by high-performance liquid chromatography. J. Pharm. Biomed. Anal. 1987, 5(5), 501–8.
  • 11. Cai, C.; Zhang, L.; Xue, F.; Qui, M.; Zheng, W. Simultaneous determination of triclabendazole and its metabolites in bovine and goat tissues by liquid chromatography–tandem mass spectrometry. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 2010, 878, 3106–12.
  • 12. Cai, C.; Xue, F.; Wang, Z.; Xiao, S.; Zhang, L. Simultaneous determination of triclabendazole and its metabolites in bovine and goat fat tissues by liquid chromatography–tandem mass spectrometry. Food Anal. Methods 2012, 5, 1260–6.
  • 13. Canas-Muller, A.; Vargas del Campo, M.; Richter, P. Determination of triclabendazole in cattle plasma as its sulfoxide and sulphone metabolites by rotating disk sorptive extraction combined with high-performance liquid chromatography and its application to pharmacokinetic studies. J. Chil. Chem. Soc. 2016, 61(4), 3195–200.
  • 14. Ceballos, L.;Moreno, L.; Alvarez, L.; Shaw, L.; Fairweather, I.; Lanusse, C. Unchanged triclabendazole kinetics after coadministration with ivermectin and methimazole:failure of its therapeutic activity against triclabendazole-resistant liver flukes. BMC Vet. Res. 2010, 6, 1–8.
  • 15. Kinsella, B.; Lehotay, S. J.; Mastovska, K.; Lightfield, A. R.; Furey, A.; Danaher, M. New method for the analysis of flukicide and other anthelmintic residues in bovine milk and liver using liquid chromatography– tandem mass spectrometry. Anal. Chim. Acta. 2009, 637, 196–207.
  • 16. Takeba, K.; Fujinuma, K.; Sakamoto, M. Simultaneous determination of triclabendazole and its sulfoxide and sulphone metabolites in bovine milk by high-performance liquid chromatography. J. Chromatogr. A. 2000, 882(1–2), 99–107.
  • 17. Guidance for Industry. Bioanalytical Method Validation. U.S. Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research (CDER). Center for Veterinary Medicine (HESI M).
  • 18. Guideline on Bioanalytical Method Validation. European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP).
  • 19. Farczadi, L.; Vlase, L.; Melles, O.; Tolomeiu, R.; Tamas-Krumpe, O.; Buta, A.; Ognean, L. The statistical analysis of pharmacokinetic parameters in the context of bioequivalence testing of two anthelmintic formulas based on ivermectine and triclabendazole in sheep. Acta Med. Marisiensis. 2019, 65(2), 60–5.
Uwagi
Opracowanie rekordu ze środków MEiN, umowa nr SONP/SP/546092/2022 w ramach programu "Społeczna odpowiedzialność nauki" - moduł: Popularyzacja nauki i promocja sportu (2022-2023).
Typ dokumentu
Bibliografia
Identyfikator YADDA
bwmeta1.element.baztech-d1977760-8f0c-4684-bf73-257168b5d10e
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