Document Detail


Liquid chromatography-mass spectrometric assay for the quantitation in human plasma of ABT-888, an orally available, small molecule inhibitor of poly(ADP-ribose) polymerase.
MedLine Citation:
PMID:  18692448     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
ABT-888, a poly(ADP-ribose) polymerase (PARP) -inhibitor in clinical trials, potentiates DNA-damaging agents. We developed and validated, according to FDA guidelines, an LC-MS assay for sensitive, accurate and precise quantitation of ABT-888 and its metabolite M8 in 0.2 mL human plasma. After ethyl acetate extraction, separation is achieved with a hydro-Synergi column and a 0.1% formic acid in acetonitrile/water-gradient. Detection uses electrospray, positive-mode ionization mass spectrometry. Between 10 (LOQ) and 1000 ng/mL, accuracy was 95.5-98.5% for ABT-888 and 91.4-100.9% for M8, and precision was 0.1-4.9% for ABT-888 and 0-13.7% for M8. The assay is being applied to samples generated in several clinical trials.
Authors:
Robert A Parise; Mohammad Shawaqfeh; Merrill J Egorin; Jan H Beumer
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Publication Detail:
Type:  Journal Article; Research Support, N.I.H., Extramural     Date:  2008-07-31
Journal Detail:
Title:  Journal of chromatography. B, Analytical technologies in the biomedical and life sciences     Volume:  872     ISSN:  1570-0232     ISO Abbreviation:  J. Chromatogr. B Analyt. Technol. Biomed. Life Sci.     Publication Date:  2008 Sep 
Date Detail:
Created Date:  2008-08-26     Completed Date:  2008-10-28     Revised Date:  2012-10-09    
Medline Journal Info:
Nlm Unique ID:  101139554     Medline TA:  J Chromatogr B Analyt Technol Biomed Life Sci     Country:  Netherlands    
Other Details:
Languages:  eng     Pagination:  141-7     Citation Subset:  IM    
Affiliation:
Molecular Therapeutics, Drug Discovery Program, University of Pittsburgh Cancer Institute, Pittsburgh, PA 15213, USA.
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MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Benzimidazoles / administration & dosage,  blood*,  pharmacokinetics
Calibration
Chromatography, Liquid / methods*
Enzyme Inhibitors / administration & dosage,  blood*,  pharmacokinetics
Humans
Poly(ADP-ribose) Polymerases / antagonists & inhibitors*
Reference Standards
Reproducibility of Results
Sensitivity and Specificity
Spectrometry, Mass, Electrospray Ionization / methods*
Grant Support
ID/Acronym/Agency:
2P30CA47904/CA/NCI NIH HHS; P30 CA047904-219021/CA/NCI NIH HHS; U01 CA099168-05/CA/NCI NIH HHS; U01 CA099168-06/CA/NCI NIH HHS; U01CA099168/CA/NCI NIH HHS; UL1 RR024153/RR/NCRR NIH HHS; UL1 RR024153/RR/NCRR NIH HHS; UL1 RR024153-01/RR/NCRR NIH HHS
Chemical
Reg. No./Substance:
0/2-((R)-2-methylpyrrolidin-2-yl)-1H-benzimidazole-4-carboxamide; 0/Benzimidazoles; 0/Enzyme Inhibitors; EC 2.4.2.30/Poly(ADP-ribose) Polymerases
Comments/Corrections

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