Rapid assay of rufinamide in dried blood spots by a new liquid chromatography-tandem mass spectrometric method

Giancarlo la Marca, Sabrina Malvagia, Luca Filippi, Marzia Innocenti, Anna Rosati, Melania Falchi, Simona Pellacani, Gloriano Moneti, Renzo Guerrini

Research output: Contribution to journalArticle

36 Citations (Scopus)

Abstract

Rufinamide (RUF) is a new antiepiletic drug with efficacy in several types of seizures. The aim of this study was to evaluate the use of dried blood spot (DBS) specimens to determinate RUF levels during treatment. Therapeutic drug monitoring of RUF could be useful in routine clinical practice. Advantages of DBS include short collection time, low invasiveness, ease and low cost of sample collection, transport and storage. The analysis was performed in selected reaction monitoring (SRM) mode. The calibration curve in matrix was linear in the concentration range of 0.008-0.8. mg/L (0.48-47.60. mg/L in DBS) of rufinamide with correlation coefficient value of 0.996. In the concentration range of 0.48-47.6. mg/L, the coefficients of variation in DBS were in the range 1.58-4.67% and the accuracy ranged from 89.73% to 107.32%.The sensitivity and specificity of tandem mass spectrometry allow now high throughput rufinamide analysis. This new assay has favourable characteristics being highly precise and accurate. The published HPLC-UV methods also proved to be precise and accurate, but required not less than 0.2-0.5. mL of plasma and are therefore unsuitable for sample collection in neonates in whom obtaining larger blood samples is not convenient or possible.

Original languageEnglish
Pages (from-to)192-197
Number of pages6
JournalJournal of Pharmaceutical and Biomedical Analysis
Volume54
Issue number1
DOIs
Publication statusPublished - Jan 2011

Fingerprint

Liquid chromatography
Liquid Chromatography
Assays
Blood
Monitoring
Drug Monitoring
Tandem Mass Spectrometry
Pharmaceutical Preparations
Calibration
Mass spectrometry
Seizures
High Pressure Liquid Chromatography
Throughput
rufinamide
Plasmas
Costs and Cost Analysis
Sensitivity and Specificity
Costs

Keywords

  • Anticonvulsant
  • Epilepsy
  • Liquid chromatography-tandem mass spectrometry
  • Rufinamide

ASJC Scopus subject areas

  • Analytical Chemistry
  • Drug Discovery
  • Pharmaceutical Science
  • Spectroscopy
  • Clinical Biochemistry

Cite this

Rapid assay of rufinamide in dried blood spots by a new liquid chromatography-tandem mass spectrometric method. / la Marca, Giancarlo; Malvagia, Sabrina; Filippi, Luca; Innocenti, Marzia; Rosati, Anna; Falchi, Melania; Pellacani, Simona; Moneti, Gloriano; Guerrini, Renzo.

In: Journal of Pharmaceutical and Biomedical Analysis, Vol. 54, No. 1, 01.2011, p. 192-197.

Research output: Contribution to journalArticle

la Marca, Giancarlo ; Malvagia, Sabrina ; Filippi, Luca ; Innocenti, Marzia ; Rosati, Anna ; Falchi, Melania ; Pellacani, Simona ; Moneti, Gloriano ; Guerrini, Renzo. / Rapid assay of rufinamide in dried blood spots by a new liquid chromatography-tandem mass spectrometric method. In: Journal of Pharmaceutical and Biomedical Analysis. 2011 ; Vol. 54, No. 1. pp. 192-197.
@article{3a3a74a0fc404803984df819aadea754,
title = "Rapid assay of rufinamide in dried blood spots by a new liquid chromatography-tandem mass spectrometric method",
abstract = "Rufinamide (RUF) is a new antiepiletic drug with efficacy in several types of seizures. The aim of this study was to evaluate the use of dried blood spot (DBS) specimens to determinate RUF levels during treatment. Therapeutic drug monitoring of RUF could be useful in routine clinical practice. Advantages of DBS include short collection time, low invasiveness, ease and low cost of sample collection, transport and storage. The analysis was performed in selected reaction monitoring (SRM) mode. The calibration curve in matrix was linear in the concentration range of 0.008-0.8. mg/L (0.48-47.60. mg/L in DBS) of rufinamide with correlation coefficient value of 0.996. In the concentration range of 0.48-47.6. mg/L, the coefficients of variation in DBS were in the range 1.58-4.67{\%} and the accuracy ranged from 89.73{\%} to 107.32{\%}.The sensitivity and specificity of tandem mass spectrometry allow now high throughput rufinamide analysis. This new assay has favourable characteristics being highly precise and accurate. The published HPLC-UV methods also proved to be precise and accurate, but required not less than 0.2-0.5. mL of plasma and are therefore unsuitable for sample collection in neonates in whom obtaining larger blood samples is not convenient or possible.",
keywords = "Anticonvulsant, Epilepsy, Liquid chromatography-tandem mass spectrometry, Rufinamide",
author = "{la Marca}, Giancarlo and Sabrina Malvagia and Luca Filippi and Marzia Innocenti and Anna Rosati and Melania Falchi and Simona Pellacani and Gloriano Moneti and Renzo Guerrini",
year = "2011",
month = "1",
doi = "10.1016/j.jpba.2010.07.015",
language = "English",
volume = "54",
pages = "192--197",
journal = "Journal of Pharmaceutical and Biomedical Analysis",
issn = "0731-7085",
publisher = "Elsevier",
number = "1",

}

TY - JOUR

T1 - Rapid assay of rufinamide in dried blood spots by a new liquid chromatography-tandem mass spectrometric method

AU - la Marca, Giancarlo

AU - Malvagia, Sabrina

AU - Filippi, Luca

AU - Innocenti, Marzia

AU - Rosati, Anna

AU - Falchi, Melania

AU - Pellacani, Simona

AU - Moneti, Gloriano

AU - Guerrini, Renzo

PY - 2011/1

Y1 - 2011/1

N2 - Rufinamide (RUF) is a new antiepiletic drug with efficacy in several types of seizures. The aim of this study was to evaluate the use of dried blood spot (DBS) specimens to determinate RUF levels during treatment. Therapeutic drug monitoring of RUF could be useful in routine clinical practice. Advantages of DBS include short collection time, low invasiveness, ease and low cost of sample collection, transport and storage. The analysis was performed in selected reaction monitoring (SRM) mode. The calibration curve in matrix was linear in the concentration range of 0.008-0.8. mg/L (0.48-47.60. mg/L in DBS) of rufinamide with correlation coefficient value of 0.996. In the concentration range of 0.48-47.6. mg/L, the coefficients of variation in DBS were in the range 1.58-4.67% and the accuracy ranged from 89.73% to 107.32%.The sensitivity and specificity of tandem mass spectrometry allow now high throughput rufinamide analysis. This new assay has favourable characteristics being highly precise and accurate. The published HPLC-UV methods also proved to be precise and accurate, but required not less than 0.2-0.5. mL of plasma and are therefore unsuitable for sample collection in neonates in whom obtaining larger blood samples is not convenient or possible.

AB - Rufinamide (RUF) is a new antiepiletic drug with efficacy in several types of seizures. The aim of this study was to evaluate the use of dried blood spot (DBS) specimens to determinate RUF levels during treatment. Therapeutic drug monitoring of RUF could be useful in routine clinical practice. Advantages of DBS include short collection time, low invasiveness, ease and low cost of sample collection, transport and storage. The analysis was performed in selected reaction monitoring (SRM) mode. The calibration curve in matrix was linear in the concentration range of 0.008-0.8. mg/L (0.48-47.60. mg/L in DBS) of rufinamide with correlation coefficient value of 0.996. In the concentration range of 0.48-47.6. mg/L, the coefficients of variation in DBS were in the range 1.58-4.67% and the accuracy ranged from 89.73% to 107.32%.The sensitivity and specificity of tandem mass spectrometry allow now high throughput rufinamide analysis. This new assay has favourable characteristics being highly precise and accurate. The published HPLC-UV methods also proved to be precise and accurate, but required not less than 0.2-0.5. mL of plasma and are therefore unsuitable for sample collection in neonates in whom obtaining larger blood samples is not convenient or possible.

KW - Anticonvulsant

KW - Epilepsy

KW - Liquid chromatography-tandem mass spectrometry

KW - Rufinamide

UR - http://www.scopus.com/inward/record.url?scp=77957017642&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=77957017642&partnerID=8YFLogxK

U2 - 10.1016/j.jpba.2010.07.015

DO - 10.1016/j.jpba.2010.07.015

M3 - Article

C2 - 20708364

AN - SCOPUS:77957017642

VL - 54

SP - 192

EP - 197

JO - Journal of Pharmaceutical and Biomedical Analysis

JF - Journal of Pharmaceutical and Biomedical Analysis

SN - 0731-7085

IS - 1

ER -