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Validation and Application of an HPLC-UV Method for Routine Therapeutic Drug Monitoring of Dalbavancin

Dalbavancin is emerging as a promising alternative in the ambulant treatment of gram-positive infections that require long-term antibiotic treatment such as osteomyelitis, prosthetic joint infections, and endocarditis. The aim of the current study was to develop and validate a simple, rapid, and cos...

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Autores principales: Chiriac, Ute, Rau, Heike, Frey, Otto R., Röhr, Anka C., Klein, Sabrina, Meyer, Anna L., Morath, Benedict
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9137512/
https://www.ncbi.nlm.nih.gov/pubmed/35625185
http://dx.doi.org/10.3390/antibiotics11050541
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author Chiriac, Ute
Rau, Heike
Frey, Otto R.
Röhr, Anka C.
Klein, Sabrina
Meyer, Anna L.
Morath, Benedict
author_facet Chiriac, Ute
Rau, Heike
Frey, Otto R.
Röhr, Anka C.
Klein, Sabrina
Meyer, Anna L.
Morath, Benedict
author_sort Chiriac, Ute
collection PubMed
description Dalbavancin is emerging as a promising alternative in the ambulant treatment of gram-positive infections that require long-term antibiotic treatment such as osteomyelitis, prosthetic joint infections, and endocarditis. The aim of the current study was to develop and validate a simple, rapid, and cost-effective high-performance liquid chromatography–ultraviolet spectrometry (HPLC–UV) method for the quantification of dalbavancin. Sample clean-up included a protein precipitation protocol, followed by chromatographic separation on a reverse phase HPLC column (C-18) with gradient elution of the mobile phase. Quantification was performed with the internal standard (caffeine) method. Linear relationships between peak area responses and drug concentrations were obtained in the range of 12.5–400 mg/L. The variation coefficient of precision and the bias of accuracy (both inter- and intraday) were less than 10%. The limit of quantification (LOQ) was 12.5 mg/L. The simple and reliable HPLC–UV assay described is a powerful tool for routine therapeutic drug monitoring (TDM) of dalbavancin in human serum in clinical laboratories. With a total process time of approximately 20 min, it allows for accurate and selective quantification up to the expected pharmacokinetic peak concentrations. The method was successfully used to analyze subsequent serum samples of three patients and showed good performance in monitoring serum levels.
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spelling pubmed-91375122022-05-28 Validation and Application of an HPLC-UV Method for Routine Therapeutic Drug Monitoring of Dalbavancin Chiriac, Ute Rau, Heike Frey, Otto R. Röhr, Anka C. Klein, Sabrina Meyer, Anna L. Morath, Benedict Antibiotics (Basel) Article Dalbavancin is emerging as a promising alternative in the ambulant treatment of gram-positive infections that require long-term antibiotic treatment such as osteomyelitis, prosthetic joint infections, and endocarditis. The aim of the current study was to develop and validate a simple, rapid, and cost-effective high-performance liquid chromatography–ultraviolet spectrometry (HPLC–UV) method for the quantification of dalbavancin. Sample clean-up included a protein precipitation protocol, followed by chromatographic separation on a reverse phase HPLC column (C-18) with gradient elution of the mobile phase. Quantification was performed with the internal standard (caffeine) method. Linear relationships between peak area responses and drug concentrations were obtained in the range of 12.5–400 mg/L. The variation coefficient of precision and the bias of accuracy (both inter- and intraday) were less than 10%. The limit of quantification (LOQ) was 12.5 mg/L. The simple and reliable HPLC–UV assay described is a powerful tool for routine therapeutic drug monitoring (TDM) of dalbavancin in human serum in clinical laboratories. With a total process time of approximately 20 min, it allows for accurate and selective quantification up to the expected pharmacokinetic peak concentrations. The method was successfully used to analyze subsequent serum samples of three patients and showed good performance in monitoring serum levels. MDPI 2022-04-19 /pmc/articles/PMC9137512/ /pubmed/35625185 http://dx.doi.org/10.3390/antibiotics11050541 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Chiriac, Ute
Rau, Heike
Frey, Otto R.
Röhr, Anka C.
Klein, Sabrina
Meyer, Anna L.
Morath, Benedict
Validation and Application of an HPLC-UV Method for Routine Therapeutic Drug Monitoring of Dalbavancin
title Validation and Application of an HPLC-UV Method for Routine Therapeutic Drug Monitoring of Dalbavancin
title_full Validation and Application of an HPLC-UV Method for Routine Therapeutic Drug Monitoring of Dalbavancin
title_fullStr Validation and Application of an HPLC-UV Method for Routine Therapeutic Drug Monitoring of Dalbavancin
title_full_unstemmed Validation and Application of an HPLC-UV Method for Routine Therapeutic Drug Monitoring of Dalbavancin
title_short Validation and Application of an HPLC-UV Method for Routine Therapeutic Drug Monitoring of Dalbavancin
title_sort validation and application of an hplc-uv method for routine therapeutic drug monitoring of dalbavancin
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9137512/
https://www.ncbi.nlm.nih.gov/pubmed/35625185
http://dx.doi.org/10.3390/antibiotics11050541
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