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Analytical validation of a novel UHPLC-MS/MS method for 19 antibiotics quantification in plasma: Implementation in a LC-MS/MS Kit.
Mula, Jacopo; Chiara, Francesco; Manca, Alessandra; Palermiti, Alice; Maiese, Domenico; Cusato, Jessica; Simiele, Marco; De Rosa, Francesco Giuseppe; Di Perri, Giovanni; De Nicolò, Amedeo; D'Avolio, Antonio.
Afiliación
  • Mula J; University of Turin, Department of Medical Sciences, Laboratory of Clinical Pharmacology and Pharmacogenetics. Amedeo di Savoia Hospital, Corso Svizzera 164, 10149 Turin, Italy. Electronic address: jacopo.mula@unito.it.
  • Chiara F; University of Turin, Department of Clinical and Biological Sciences, Laboratory of Clinical Pharmacology San Luigi A.O.U., Regione Gonzole 10, 10043 Orbassano, TO, Italy.
  • Manca A; University of Turin, Department of Medical Sciences, Laboratory of Clinical Pharmacology and Pharmacogenetics. Amedeo di Savoia Hospital, Corso Svizzera 164, 10149 Turin, Italy.
  • Palermiti A; University of Turin, Department of Medical Sciences, Laboratory of Clinical Pharmacology and Pharmacogenetics. Amedeo di Savoia Hospital, Corso Svizzera 164, 10149 Turin, Italy.
  • Maiese D; University of Turin, Department of Medical Sciences, Laboratory of Clinical Pharmacology and Pharmacogenetics. Amedeo di Savoia Hospital, Corso Svizzera 164, 10149 Turin, Italy.
  • Cusato J; University of Turin, Department of Medical Sciences, Laboratory of Clinical Pharmacology and Pharmacogenetics. Amedeo di Savoia Hospital, Corso Svizzera 164, 10149 Turin, Italy.
  • Simiele M; CoQua Lab srl, Spin-Off of University of Turin, Operational Headquarters, C.so Svizzera185 bis (Block 3, Staircase C, 3rd floor), 10149 Torino, Italy.
  • De Rosa FG; University of Turin, Department of Medical Sciences, Infectious Diseases, Italy.
  • Di Perri G; University of Turin, Department of Medical Sciences, Infectious Diseases, Italy.
  • De Nicolò A; University of Turin, Department of Medical Sciences, Laboratory of Clinical Pharmacology and Pharmacogenetics. Amedeo di Savoia Hospital, Corso Svizzera 164, 10149 Turin, Italy.
  • D'Avolio A; University of Turin, Department of Medical Sciences, Laboratory of Clinical Pharmacology and Pharmacogenetics. Amedeo di Savoia Hospital, Corso Svizzera 164, 10149 Turin, Italy.
Biomed Pharmacother ; 163: 114790, 2023 Jul.
Article en En | MEDLINE | ID: mdl-37126927
BACKGROUND: Therapeutic drug monitoring (TDM) for antibiotic drugs represents a consolidated practice to optimize the effectiveness and to limit the toxicity of specific drugs by guiding dosage adjustments. The comparison of TDM results with drug-specific pharmacokinetic/pharmacodynamic (PK/PD) parameters, based on killing dynamics and bacterial susceptibility, increases the probability of therapeutic success. PURPOSE: The aim of this study was the analytical validation of a new UHPLC-MS/MS assay for the quantification of 19 antibiotics divided in two different sets considering their chemical/pharmacological properties. This method has been implemented in an analytical LC-MS/MS Kit System by CoQua Lab s.r.l (Turin). METHODS: The analytical validation is developed in accordance with "ICH Harmonized Guideline M10 on bioanalytical method validation and study sample analysis" and "Guidelines for regulatory auditing of quality management system of medical device manufacturers". Method suitability in the clinical context was tested by analysing clinical samples from patients treated with antibiotic drugs. RESULTS: This method allows for simultaneous TDM of the following molecules: dalbavancin, daptomycin, linezolid, tedizolid, levofloxacin, moxifloxacin, meropenem, ertapenem, vaborbactam, avibactam, sulbactam, tazobactam, ceftazidime, ceftriaxone, ceftolozane, ceftobiprole, cefiderocol, ceftaroline and piperacillin. These drugs were quantified showing analytical performance parameters compliant with guidelines in terms of repeatability, reproducibility, robustness, bias, LOD, LOQ and linearity. The method was capable to successfully monitor drug concentrations in 65 samples from 52 patients undergoing treatment. CONCLUSION: The UHPLC-MS/MS method described in this work can be useful for TDM of the reported antimicrobial agents. The analytical protocol is rapid and suitable to be used in routine analysis.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Espectrometría de Masas en Tándem / Antibacterianos Tipo de estudio: Guideline Límite: Humans Idioma: En Revista: Biomed Pharmacother Año: 2023 Tipo del documento: Article Pais de publicación: Francia
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Espectrometría de Masas en Tándem / Antibacterianos Tipo de estudio: Guideline Límite: Humans Idioma: En Revista: Biomed Pharmacother Año: 2023 Tipo del documento: Article Pais de publicación: Francia