High performance liquid chromatography coupled with mass spectrometry for simultaneous determination of rivastigmine and its metabolite in rat plasma

• Autorzy: Sato Yuhki , Michihara Ayana , Nagatsuka Handa Yuka , Yamamoto Kouichi , Shirakawa Makoto , Katayama Hirokazu

Identyfikatory

DOI

10.1556/1326.2021.00989

• Języki publikacji: EN

Abstrakty

EN

Several studies on the pharmacokinetic parameters of antidementia drugs have reported that plasma concentration is linked to the drugs’ efficacy and adverse effects. At present, there is no quantitation method that is highly sensitive and can be applied to simultaneous monitoring of the pharmacokinetics of rivastigmine and its metabolites (NAP 226-90) in rat plasma. No methods fulfilling the assay validation requirements of the US Food and Drug Administration and the European Medicines Agency was also established. Therefore, this study developed a quantitative method for measuring rivastigmine and NAP 226-90 concentrations using high-performance liquid chromatography and tandem mass spectrometry, examining plasma samples after rivastigmine administration. Rat plasma samples were prepared via the protein precipitation method. The methods for measuring rivastigmine and NAP 226-90 concentrations showed good fit over wide ranges of 1–100 ng mL⁻¹ and 0.5–50 ng mL⁻¹, with lower limits of quantification at 1 ng mL⁻¹ and 0.5 ng mL⁻¹, respectively. The plasma concentrations of rivastigmine and NAP 226-90 in six healthy rats were successfully determined, demonstrating the feasibility of applying the developed method. Thus, this research has successfully developed a sensitive, selective method, to simultaneously quantify rivastigmine and NAP 226-90 concentrations in rat plasma and be applicable to a pharmacokinetic study.

Słowa kluczowe

EN

rivastigmine; NAP 226-90; tandem mass spectrometry; high performance liquid chromatography

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2022
• Tom: Vol. 34, no. 4
• Strony: 437--443
• Opis fizyczny: Bibliogr. 10 poz., tab., wykr.

Twórcy

autor

Sato Yuhki

• Department of Pharmaceutical Sciences, Faculty of Pharmacy and Pharmaceutical Sciences, Fukuyama University, Fukuyama-shi, Hiroshima, 7290292, Japan

• https://orcid.org/0000-0002-2245-4981

autor

Michihara Ayana

• Department of Pharmaceutical Sciences, Faculty of Pharmacy and Pharmaceutical Sciences, Fukuyama University, Fukuyama-shi, Hiroshima, 7290292, Japan

autor

Nagatsuka Handa Yuka

• Department of Pharmaceutical Sciences, Faculty of Pharmacy and Pharmaceutical Sciences, Fukuyama University, Fukuyama-shi, Hiroshima, 7290292, Japan

autor

Yamamoto Kouichi

• Department of Radiological Sciences, Faculty of Health Sciences, Morinomiya University of Medical Sciences, Suminoe-ku, Osaka, Japan

autor

Shirakawa Makoto

• Department of Pharmaceutical Sciences, Faculty of Pharmacy and Pharmaceutical Sciences, Fukuyama University, Fukuyama-shi, Hiroshima, 7290292, Japan

autor

Katayama Hirokazu

• Department of Pharmaceutical Sciences, Faculty of Pharmacy and Pharmaceutical Sciences, Fukuyama University, Fukuyama-shi, Hiroshima, 7290292, Japan

Bibliografia

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• 6. FDA. US Department of Health and Human Services, Food and Drug Administration. Guidance for industry, bioanalytical method validation, 2018. https://www.fda.gov/media/70858/download (accessed July 23, 2021).
• 7. EMA. European Medicines Agency. Guideline on bioanalytical method validation, 2012. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf (accessed July 23, 2021).
• 8. Karasova, J. Z.; Hrabinova, M.; Krejciova, M.; Jun, D.; Kuca, K. Iran J. Pharm. 2020, 19, 95–102.
• 9. Nakamura, Y.; Imai, Y.; Shigeta, M.; Graf, A.; Shirahase, T.; Kim, H.; Fujii, A.; Mori, J.; Homma, A. Dement. Geriatr. Cogn. Dis. Extra. 2011, 1(1), 163–79.
• 10. Ueda, K.; Katayama, S.; Arai, T.; Furuta, N.; Ikebe, S.; Ishida, Y.; Kanaya, K.; Ouma, S.; Sakurai, H.; Sugitani, M.; Takahashi, M.; Tanaka, T.; Tsuno, N.; Wakutani, Y.; Shekhawat, A.; Das Gupta, A.; Kiyose, K.; Toriyama, K.; Nakamura, Y. Dement. Geriatr. Cogn. Dis. Extra. 2019, 9(2), 302–18.

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).