Determination of telaprevir in plasma of HCV-infected patients by HPLC-UV

Massimo Tempestilli, Elisa Milano, Gianpiero D'Offizi, Marzia Montalbano, Antonio D'Avolio, Tecla Gasperi, Pasquale Narciso, Paolo Ascenzi, Leopoldo P. Pucillo

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

Telaprevir is a direct acting antiviral agent, used with pegylated interferon and ribavirin for the management of chronic hepatitis C virus (HCV) genotype 1 infection, in patients not responding to therapy with pegylated interferon and ribavirin only. Although 75% of patients achieve a sustained virological response after treatment with telaprevir, adverse drug-drug interactions and undesirable events often occur. Therefore, telaprevir monitoring is pivotal to improve the management of HCV infection. Here, the first High-Performance Liquid Chromatography-Ultraviolet (HPLC-UV) method to quantify telaprevir in human plasma of HCV-genotype 1-infected patients is reported. The volume of the plasma sample was 700 μL. This method involved automated solid-phase extraction with Oasis HLB Cartridge 1 cc (divinylbenzene and N-vinylpyrrolidone). The extracted samples were reconstituted with 150 μL of 60/40 water/acetonitrile. Thirty microliters of these samples was injected into a HPLC-UV system, and the analytes were eluted on a X Terra® RP18 column (250 mm × 4.6 mm i.d.) with a particle size of 5 μm. The mobile phase (ammonium acetate buffer, 150 mM, pH 8.0, and methanol:acetonitrile 50:50) was delivered at 1.0 mL/min with linear gradient elution. The total run time for a single analysis was 16 min; telaprevir was detected by UV at 276 and 286 nm. The calibration curve was linear from 312.5 to 20,000 ng/mL (r2 > 0.996). The absolute recovery of telaprevir ranged between 89 and 93% at concentrations of quality control samples of 800, 4,000, 8,000, and 16,000 ng/mL. Both precision and accuracy were always

Original languageEnglish
Pages (from-to)800-805
Number of pages6
JournalIUBMB Life
Volume65
Issue number9
DOIs
Publication statusPublished - Sep 2013

Fingerprint

High performance liquid chromatography
Viruses
Hepacivirus
High Pressure Liquid Chromatography
Plasmas
divinyl benzene
Ribavirin
Interferons
Genotype
Drug interactions
Plasma (human)
Plasma Volume
Solid Phase Extraction
Chronic Hepatitis C
Virus Diseases
Drug Interactions
Particle Size
Quality Control
Calibration
Antiviral Agents

Keywords

  • anti-HCV therapy
  • HPLC-UV
  • telaprevir
  • therapeutic drug monitoring

ASJC Scopus subject areas

  • Biochemistry
  • Cell Biology
  • Clinical Biochemistry
  • Molecular Biology
  • Genetics

Cite this

Determination of telaprevir in plasma of HCV-infected patients by HPLC-UV. / Tempestilli, Massimo; Milano, Elisa; D'Offizi, Gianpiero; Montalbano, Marzia; D'Avolio, Antonio; Gasperi, Tecla; Narciso, Pasquale; Ascenzi, Paolo; Pucillo, Leopoldo P.

In: IUBMB Life, Vol. 65, No. 9, 09.2013, p. 800-805.

Research output: Contribution to journalArticle

Tempestilli, M, Milano, E, D'Offizi, G, Montalbano, M, D'Avolio, A, Gasperi, T, Narciso, P, Ascenzi, P & Pucillo, LP 2013, 'Determination of telaprevir in plasma of HCV-infected patients by HPLC-UV', IUBMB Life, vol. 65, no. 9, pp. 800-805. https://doi.org/10.1002/iub.1197
Tempestilli, Massimo ; Milano, Elisa ; D'Offizi, Gianpiero ; Montalbano, Marzia ; D'Avolio, Antonio ; Gasperi, Tecla ; Narciso, Pasquale ; Ascenzi, Paolo ; Pucillo, Leopoldo P. / Determination of telaprevir in plasma of HCV-infected patients by HPLC-UV. In: IUBMB Life. 2013 ; Vol. 65, No. 9. pp. 800-805.
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