Development and application of an LC–MS/MS method for quantification of fosmidomycin in human and rat plasma

Abstract Background Malaria still poses a significant burden on global health, with millions of cases reported annually and rising resistance to current treatments, emphasizing the need for new therapeutic strategies. Fosmidomycin, initially recognized for its antibacterial properties, has emerged a...

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Main Authors: Christoph Pfaffendorf, Keanu D. Sackmann, Johannes Mischlinger, Jean Claude Dejon-Agobé, Oumou Maïga-Ascofaré, Ebenezer Ahenkan, Ayôla Akim Adegnika, Michael Ramharter, Philipp Uhl, Gert Fricker, Sebastian G. Wicha
Format: Article
Language:English
Published: BMC 2025-07-01
Series:Malaria Journal
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Online Access:https://doi.org/10.1186/s12936-025-05489-1
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author Christoph Pfaffendorf
Keanu D. Sackmann
Johannes Mischlinger
Jean Claude Dejon-Agobé
Oumou Maïga-Ascofaré
Ebenezer Ahenkan
Ayôla Akim Adegnika
Michael Ramharter
Philipp Uhl
Gert Fricker
Sebastian G. Wicha
author_facet Christoph Pfaffendorf
Keanu D. Sackmann
Johannes Mischlinger
Jean Claude Dejon-Agobé
Oumou Maïga-Ascofaré
Ebenezer Ahenkan
Ayôla Akim Adegnika
Michael Ramharter
Philipp Uhl
Gert Fricker
Sebastian G. Wicha
author_sort Christoph Pfaffendorf
collection DOAJ
description Abstract Background Malaria still poses a significant burden on global health, with millions of cases reported annually and rising resistance to current treatments, emphasizing the need for new therapeutic strategies. Fosmidomycin, initially recognized for its antibacterial properties, has emerged as a promising candidate in the fight against malaria. Methods In this study, a sensitive and robust LC–MS/MS method for quantifying fosmidomycin in human and rat plasma was developed and validated. Plasma samples were prepared using a simple protein precipitation method with 10% trichloroacetic acid (TCA). The assay featured a rapid run time of 5 min, and validation was performed according to the European Medicines Agency's guidelines. Results The method validation confirmed its selectivity, linearity, accuracy, precision, and stability. Notably, the calibration range was established from 0.25 to 15 mg/L, demonstrating improvements over previous methodologies with lower limits of quantification of 0.5–1.0 mg/L. Using the developed LC–MS/MS method, plasma samples were analysed from a clinical trial conducted in Gabon, as well as from a pharmacokinetic study involving male Wistar rats, revealing viable pharmacokinetic profiles for fosmidomycin. Conclusions These findings confirm the utility of the developed analytical method for supporting the clinical development of fosmidomycin as a potential therapy for malaria.
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issn 1475-2875
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series Malaria Journal
spelling doaj-art-0c9fc3f11fb649db9cbbc67ceab0651d2025-08-20T03:42:34ZengBMCMalaria Journal1475-28752025-07-0124111110.1186/s12936-025-05489-1Development and application of an LC–MS/MS method for quantification of fosmidomycin in human and rat plasmaChristoph Pfaffendorf0Keanu D. Sackmann1Johannes Mischlinger2Jean Claude Dejon-Agobé3Oumou Maïga-Ascofaré4Ebenezer Ahenkan5Ayôla Akim Adegnika6Michael Ramharter7Philipp Uhl8Gert Fricker9Sebastian G. Wicha10Institute of Pharmacy, Dept. of Clinical Pharmacy, University of HamburgInstitute of Pharmacy, Dept. of Clinical Pharmacy, University of HamburgCentre for Tropical Medicine, Department of Medicine, Bernhard Nocht Institute for Tropical Medicine, University Medical Center Hamburg-EppendorfCentre de Recherches Médicales de LambarénéKumasi Centre for Collaborative Research in Tropical MedicineKumasi Centre for Collaborative Research in Tropical MedicineCentre de Recherches Médicales de LambarénéCentre for Tropical Medicine, Department of Medicine, Bernhard Nocht Institute for Tropical Medicine, University Medical Center Hamburg-EppendorfInstitute of Pharmacy and Molecular Biotechnology, Ruprecht-Karls-UniversityInstitute of Pharmacy and Molecular Biotechnology, Ruprecht-Karls-UniversityInstitute of Pharmacy, Dept. of Clinical Pharmacy, University of HamburgAbstract Background Malaria still poses a significant burden on global health, with millions of cases reported annually and rising resistance to current treatments, emphasizing the need for new therapeutic strategies. Fosmidomycin, initially recognized for its antibacterial properties, has emerged as a promising candidate in the fight against malaria. Methods In this study, a sensitive and robust LC–MS/MS method for quantifying fosmidomycin in human and rat plasma was developed and validated. Plasma samples were prepared using a simple protein precipitation method with 10% trichloroacetic acid (TCA). The assay featured a rapid run time of 5 min, and validation was performed according to the European Medicines Agency's guidelines. Results The method validation confirmed its selectivity, linearity, accuracy, precision, and stability. Notably, the calibration range was established from 0.25 to 15 mg/L, demonstrating improvements over previous methodologies with lower limits of quantification of 0.5–1.0 mg/L. Using the developed LC–MS/MS method, plasma samples were analysed from a clinical trial conducted in Gabon, as well as from a pharmacokinetic study involving male Wistar rats, revealing viable pharmacokinetic profiles for fosmidomycin. Conclusions These findings confirm the utility of the developed analytical method for supporting the clinical development of fosmidomycin as a potential therapy for malaria.https://doi.org/10.1186/s12936-025-05489-1FosmidomycinLC–MS/MSPharmacokineticsBioanalysisMalaria
spellingShingle Christoph Pfaffendorf
Keanu D. Sackmann
Johannes Mischlinger
Jean Claude Dejon-Agobé
Oumou Maïga-Ascofaré
Ebenezer Ahenkan
Ayôla Akim Adegnika
Michael Ramharter
Philipp Uhl
Gert Fricker
Sebastian G. Wicha
Development and application of an LC–MS/MS method for quantification of fosmidomycin in human and rat plasma
Malaria Journal
Fosmidomycin
LC–MS/MS
Pharmacokinetics
Bioanalysis
Malaria
title Development and application of an LC–MS/MS method for quantification of fosmidomycin in human and rat plasma
title_full Development and application of an LC–MS/MS method for quantification of fosmidomycin in human and rat plasma
title_fullStr Development and application of an LC–MS/MS method for quantification of fosmidomycin in human and rat plasma
title_full_unstemmed Development and application of an LC–MS/MS method for quantification of fosmidomycin in human and rat plasma
title_short Development and application of an LC–MS/MS method for quantification of fosmidomycin in human and rat plasma
title_sort development and application of an lc ms ms method for quantification of fosmidomycin in human and rat plasma
topic Fosmidomycin
LC–MS/MS
Pharmacokinetics
Bioanalysis
Malaria
url https://doi.org/10.1186/s12936-025-05489-1
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