A validated simultaneous quantification method for vonoprazan (TAK-438F) and its 4 metabolites in human plasma by the liquid chromatography-tandem mass spectrometry

Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
Tomoki YoneyamaSatoru Asahi

Abstract

Vonoprazan fumarate (TAK-438) is a potassium-competitive acid blocker which was approved in Japan for a treatment of acid-related diseases. In this study a simple and validated bioanalytical method, which can simultaneously determine vonoprazan (TAK-438F) and its four metabolites (M-I, M-II, M-III and M-IV-Sul) in human plasma, was developed. The method is based on protein precipitation and subsequent ultra-high performance liquid chromatography separation followed by tandem mass spectrometry detection. The mass spectrometric parameters for detection of TAK-438F, M-I, M-III and M-IV-Sul were modified from their optimum values in order to achieve a simultaneous quantification while retaining enough sensitivity and wide dynamic ranges for all the target analytes. The validity and robustness of the method was verified through a validation study as per the regulatory guidance on bioanalytical method validation. The calibration ranges are 0.1-100 ng/mL for TAK-438F and M-III, and 1-1000 ng/mL for M-I, M-II and M-IV-Sul using the 100 μL of human plasma. The total run time per sample is 5 min. The working solution for M-III was recommended to be prepared separately, especially for the long-term use, in order to avoid the instability o...Continue Reading

References

May 22, 2009·Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences·Femke de VeldeDonald R A Uges
Jan 15, 2010·Basic & Clinical Pharmacology & Toxicology·José Augusto Guimarães Morais, Maria do Rosário Lobato
Mar 18, 2011·The Journal of Pharmacology and Experimental Therapeutics·Yasunobu HoriNobuhiro Inatomi
Sep 24, 2011·Journal of Biomolecular Screening·Mitsuyo KondoNaoki Tarui
Jul 7, 2012·Journal of Pain & Palliative Care Pharmacotherapy·UNKNOWN Food And Drug Administration, Public Health Service, U.S. Department Of Health And Human Services
Feb 2, 2013·Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences·Mahmoud YacoubTawfiq Arafat

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Citations

Jul 15, 2016·Xenobiotica; the Fate of Foreign Compounds in Biological Systems·Hitomi YamasakiSatoru Asahi
Oct 27, 2018·European Journal of Drug Metabolism and Pharmacokinetics·Mitsuhiro NishiharaHelen Jenkins
Jun 26, 2020·Drug Design, Development and Therapy·Jiquan ShenBin Liu

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