A rapid, accurate and robust UHPLC-MS/MS method for quantitative determination of BMS-927711, a CGRP receptor antagonist, in plasma in support of non-clinical toxicokinetic studies

Journal of Pharmaceutical and Biomedical Analysis

Volumn 83, Issue , 2013, Pages 237-248

  Zheng, Naiyu ^a   Zeng, Jianing ^a   Akinsanya, Billy ^a   Buzescu, Adela ^a   Xia, Yuan Qing ^a,b   Ly, Van ^a   Trouba, Kevin ^a   Peng, Qianping ^a   Aubry, Anne Françoise ^a   Arnold, Mark E ^a  

^a BRISTOL MYERS SQUIBB   (United States)

^b MDS SCIEX   (Canada)

Author keywords

BMS 927711; CGRP antagonist; N carbamoyl glucuronide; Quantitation; Stability; UHPLC MS MS

Indexed keywords

BMS 927711; CALCITONIN GENE RELATED PEPTIDE RECEPTOR ANTAGONIST; DRUG METABOLITE; UNCLASSIFIED DRUG;

ANIMAL TISSUE; ARTICLE; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG DETERMINATION; DRUG METABOLISM; HAPLORHINI; LIMIT OF DETECTION; LIMIT OF QUANTITATION; LIQUID LIQUID EXTRACTION; MEASUREMENT ACCURACY; MOUSE; NONHUMAN; PRIORITY JOURNAL; QUALITY CONTROL; RABBIT; RAT; TANDEM MASS SPECTROMETRY; ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY;

ANIMALS; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; GLUCURONIDES; HAPLORHINI; LIQUID-LIQUID EXTRACTION; MICE; PIPERIDINES; PYRIDINES; RABBITS; RATS; RECEPTORS, CALCITONIN GENE-RELATED PEPTIDE; REFERENCE STANDARDS; TANDEM MASS SPECTROMETRY;

EID: 84879269475     PISSN: 07317085     EISSN: 1873264X     Source Type: Journal    
DOI: 10.1016/j.jpba.2013.05.019     Document Type: Article

References (18)

1. Victor T.W., Hu X., Campbell J.C., Buse D.C., Lipton R.B. Migraine prevalence by age and sex in the United States: a life-span study. Cephalalgia 2010, 30:1065-1072.
2. Lipton R.B., Stewart W.F., Diamond S., Diamond M.L., Reed M. Prevalence and burden of migraine in the United States: data from the American migraine study II. Headache 2001, 41:646-657.
3. Diener H.C., Limmroth V. Advances in pharmacological treatment of migraine. Expert Opin. Investig. Drugs 2001, 10:1831-1845.
4. Ferrari M.D., Goadsby P.J., Roon K.I., Lipton R.B. Triptans (serotonin, 5-HT1B/1D agonists) in migraine: detailed results and methods of a meta-analysis of 53 trials. Cephalalgia 2002, 22:633-658.
5. Hoffmann J., Goadsby P.J. New agents for acute treatment of migraine: CGRP receptor antagonists, iNOS Inhibitors. Curr. Treat. Options Neurol. 2012, 14:50-59.
6. Negro A., Lionetto L., Simmaco M., Martelletti P. CGRP receptor antagonists: an expanding drug class for acute migraine?. Expert Opin. Investig. Drugs 2012, 21:807-818.
7. Luo G., Chen L., Conway C.M., Denton R., Keavy D., Signor L., Kostich W., Lentz K.A., Santone K.S., Schartman R., Browning M., Tong G., Houston J.G., Dubowchik G.M., Macor J.E. Discovery of (5S,6S,9R)-5-amino-6-(2,3-difluorophenyl)-6,7,8,9-tetrahydro-5H-cyclohepta[b]pyridin-9-yl 4-(2-oxo-2,3-dihydro-1H-imidazo[4,5-b]pyridin-1-yl)piperidine-1-carboxylate (BMS-927711): an oral calcitonin gene-related peptide (CGRP) antagonist in clinical trials for treating migraine. J. Med. Chem. 2012, 55:10644-10651.
8. Jemal M., Ouyang Z., Xia Y.Q. Systematic LC-MS/MS bioanalytical method development that incorporates plasma phospholipids risk avoidance, usage of incurred sample and well thought-out chromatography. Biomed. Chromatogr. 2010, 24:2-19.
9. Jiang H., Zeng J., Deng Y., Xia Y.Q., Ouyang Z., Jemal M., Salcedo T.W., Arnold M.E. A rugged and accurate liquid chromatography-tandem mass spectrometry method for quantitative determination of BMS-790052 in plasma. J. Chromatogr. B 2011, 879:2064-2072.
10. Yuan L., Jiang H., Ouyang Z., Xia Y.Q., Zeng J., Peng Q., Lange R.W., Deng Y., Arnold M.E., Aubry A. A rugged and accurate liquid chromatography-tandem mass spectrometry method for the determination of asunaprevir, an NS3 protease inhibitor, in plasma. J. Chromatogr. B 2013, 921/922:81-86.
11. Jemal M., Xia Y.Q. LC-MS development strategies for quantitative bioanalysis. Curr. Drug Metab. 2006, 7:491-502.
12. Xu R.N., Fan L., Rieser M.J., El-Shourbagy T.A. Recent advances in high-throughput quantitative bioanalysis by LC-MS/MS. J. Pharm. Biomed. Anal. 2007, 44:342-355.
13. Liu G., Snapp H.M., Ji Q.C., Arnold M.E. Strategy of accelerated method development for high-throughput bioanalytical assays using ultra high-performance liquid chromatography coupled with mass spectrometry. Anal. Chem. 2009, 81:9225-9232.
14. Food and Drug Administration Guidance for Industry: Bioanalytical Method Validation 2001, US Department of Health and Human Services, FDA, Center for Drug Evaluation and Research, Rockville, MD.
15. Viswanathan C.T., Bansal S., Booth B., DeStefano A.J., Rose M.J., Sailstad J., Shah V.P., Skelly J.P., Swann P.G., Weiner R. Workshop/conference report - quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays. AAPS J. 2007, 9:E30-E42.
16. Gunduz M., Argikar U.A., Baeschlin D., Ferreira S., Hosagrahara V., Harriman S. Identification of a novel N-carbamoyl glucuronide: in vitro, in vivo, and mechanistic studies. Drug Metab. Dispos. 2010, 38:361-367.
17. Liu D.Q., Pereira T. Interference of a carbamoyl glucuronide metabolite in quantitative liquid chromatography/tandem mass spectrometry. Rapid Commun. Mass Spectrom. 2002, 16:142-146.
18. Xia Y.Q., Jemal M. Phospholipids in liquid chromatography/mass spectrometry bioanalysis: comparison of three tandem mass spectrometric techniques for monitoring plasma phospholipids, the effect of mobile phase composition on phospholipids elution and the association of phospholipids with matrix effects. Rapid Commun. Mass Spectrom. 2009, 23:2125-2138.