Development and validation of an integrated LC-MS/MS assay for therapeutic drug monitoring of five PARP-inhibitors

M. A.C. Bruin, N. de Vries, L. Lucas, H. Rosing, A. D.R. Huitema, J. H. Beijnen

Onderzoeksoutput: Bijdrage aan tijdschriftArtikelpeer review

2 Citaten (Scopus)

Samenvatting

An liquid chromatography-mass spectrometry (LC-MS/MS) assay was developed for the combined analysis of the five poly (ADP-ribose) polymerase (PARP) inhibitors niraparib, olaparib, rucaparib talazoparib and veliparib. A simple and fast sample pre-treatment method was used by protein precipitating of plasma samples with acetonitrile and dilution of the supernatant with formic acid (0.1% v/v in water). This was followed by chromatographic separation on a reversed-phase UPLC BEH C18 column and detection with a triple quadrupole mass spectrometer operating in the positive mode. A simplified validation procedure specifically designed for bioanalytical methods for clinical therapeutic drug monitoring (TDM) purposes, was applied. This included assessment of the calibration model, accuracy and precision, lower limit of quantification (LLOQ), specificity and selectivity, carry-over and stability. The validated range was 30–3000 ng/mL for niraparib, 100–10,000 ng/mL for olaparib, 50–5000 ng/mL for rucaparib, 0.5–50 ng/mL for talazoparib and 50–5000 for veliparib. All results were within the criteria of the US Food and Drug Administration (FDA) guidance and European Medicines Agency (EMA) guidelines on method validation. The assay has been successfully implemented in our laboratory.

Originele taal-2Engels
Artikelnummer121925
TijdschriftJournal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences
Volume1138
DOI's
StatusGepubliceerd - 1 feb. 2020
Extern gepubliceerdJa

Vingerafdruk

Duik in de onderzoeksthema's van 'Development and validation of an integrated LC-MS/MS assay for therapeutic drug monitoring of five PARP-inhibitors'. Samen vormen ze een unieke vingerafdruk.

Citeer dit