Perampanel dosage in plasma samples: development and validation of a novel HPLC method with combined UV-Fluorescence detection.


Journal

Journal of pharmaceutical and biomedical analysis
ISSN: 1873-264X
Titre abrégé: J Pharm Biomed Anal
Pays: England
ID NLM: 8309336

Informations de publication

Date de publication:
10 Sep 2021
Historique:
received: 29 03 2021
revised: 04 07 2021
accepted: 05 07 2021
pubmed: 16 7 2021
medline: 25 8 2021
entrez: 15 7 2021
Statut: ppublish

Résumé

Therapeutic drug monitoring (TDM) is a recognized method to improve the quality of use of antiepileptic drugs, such as perampanel (PRP). It is the first compound in the class of selective non-competitive antagonists of AMPA receptors approved in 2012 in Europe and United States for adjunctive therapy of partial seizures. Although several studies have recently underlined that a general reference range for PRP plasmatic concentration might be difficult to propose, TDM of this drug is important in specific clinical situations, as hepatic or renal impairment or co-administration with enzyme-inducing antiepileptics. Several methods have been described in literature for the determination of PRP in different biological matrices, which include the use of liquid chromatography methods coupled with ultraviolet, fluorescence, mass or tandem-mass spectrometry detection. Here we describe the development and validation of a novel method for the measurement of PRP in plasma samples, based on a HPLC-UV/FL double detection approach and using ketoprofen as internal standard. PRP concentration in a small subset of plasma samples of treated patients was evaluated using both our approach and a commercially available CE-IVD LC-MS/MS method. The results obtained were compared, and confirmed the possibility to use our method as an alternative to LC-MS/MS in clinical routine.

Identifiants

pubmed: 34265485
pii: S0731-7085(21)00363-0
doi: 10.1016/j.jpba.2021.114252
pii:
doi:

Substances chimiques

Nitriles 0
Pharmaceutical Preparations 0
Pyridones 0
perampanel H821664NPK

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

114252

Informations de copyright

Copyright © 2021 Elsevier B.V. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Auteurs

Bruno Charlier (B)

Department of Medicine, Surgery and Dentistry "Scuola Medica Salernitana", University of Salerno, Via Salvador Allende 84081, Baronissi, Salerno, Italy; University Hospital "San Giovanni di Dio e Ruggi D'Aragona", Via San Leonardo 84131, Salerno, Italy.

Albino Coglianese (A)

Department of Medicine, Surgery and Dentistry "Scuola Medica Salernitana", University of Salerno, Via Salvador Allende 84081, Baronissi, Salerno, Italy.

Francesca Felicia Operto (FF)

University Hospital "San Giovanni di Dio e Ruggi D'Aragona", Via San Leonardo 84131, Salerno, Italy.

Federica De Rosa (F)

Department of Medicine, Surgery and Dentistry "Scuola Medica Salernitana", University of Salerno, Via Salvador Allende 84081, Baronissi, Salerno, Italy; University Hospital "San Giovanni di Dio e Ruggi D'Aragona", Via San Leonardo 84131, Salerno, Italy.

Francesca Mensitieri (F)

Department of Medicine, Surgery and Dentistry "Scuola Medica Salernitana", University of Salerno, Via Salvador Allende 84081, Baronissi, Salerno, Italy.

Giangennaro Coppola (G)

Department of Medicine, Surgery and Dentistry "Scuola Medica Salernitana", University of Salerno, Via Salvador Allende 84081, Baronissi, Salerno, Italy; University Hospital "San Giovanni di Dio e Ruggi D'Aragona", Via San Leonardo 84131, Salerno, Italy.

Amelia Filippelli (A)

Department of Medicine, Surgery and Dentistry "Scuola Medica Salernitana", University of Salerno, Via Salvador Allende 84081, Baronissi, Salerno, Italy; University Hospital "San Giovanni di Dio e Ruggi D'Aragona", Via San Leonardo 84131, Salerno, Italy.

Fabrizio Dal Piaz (F)

Department of Medicine, Surgery and Dentistry "Scuola Medica Salernitana", University of Salerno, Via Salvador Allende 84081, Baronissi, Salerno, Italy; University Hospital "San Giovanni di Dio e Ruggi D'Aragona", Via San Leonardo 84131, Salerno, Italy.

Viviana Izzo (V)

Department of Medicine, Surgery and Dentistry "Scuola Medica Salernitana", University of Salerno, Via Salvador Allende 84081, Baronissi, Salerno, Italy; University Hospital "San Giovanni di Dio e Ruggi D'Aragona", Via San Leonardo 84131, Salerno, Italy. Electronic address: vizzo@unisa.it.

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Classifications MeSH