Rapid identification and absence of drug tests for AG-013736 in 1mg Axitinib tablets by ion mobility spectrometry and DART™ mass spectrometry

Journal of Pharmaceutical and Biomedical Analysis

Volumn 55, Issue 3, 2011, Pages 569-573

  Likar, Michael D ^a   Cheng, Guilong ^a   Mahajan, Nidhi ^a   Zhang, Zhongli ^a  

^a PFIZER INC   (United States)

Author keywords

Axitinib; Direct analysis in real time; Ion mobility spectrometry; Mass spectrometry

Indexed keywords

AXITINIB;

ARTICLE; DIRECT ANALYSIS IN REAL TIME MASS SPECTROMETRY; DRUG IDENTIFICATION; DRUG SCREENING; ION MOBILITY SPECTROMETRY; ION TRAP MASS SPECTROMETRY; MASS SPECTROMETRY; PRIORITY JOURNAL; TABLET; TIME OF FLIGHT MASS SPECTROMETRY;

ANTINEOPLASTIC AGENTS; DRUGS, INVESTIGATIONAL; IMIDAZOLES; INDAZOLES; MASS SPECTROMETRY; MOLECULAR STRUCTURE; PLACEBOS; TABLETS; TIME FACTORS;

EID: 79953226215     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2011.02.021     Document Type: Article

References (21)

1. Rini B.I., Wilding G., Hudes G., Stadler W.M., Kim S., Tarazi J., Rosbrook B., Trask P.C., Wood L., Dutcher J.P. Phase II study of axitinib in sorafenib-refractory metastatic renal cell carcinoma. J. Clin. Oncol. 2009, 27:4462-4468.
2. Schiller J.H., Larson T., Ou S.-H.I., Limentani S., Sandler A., Vokes E., Kim S., Liau K., Bycott P., Olszanski A.J., von Pawel J. Efficacy and safety of axitinib in patients with advanced non-small-cell lung cancer: results from a phase II study. J. Clin. Oncol. 2009, 27:3836-3841.
3. Cohen E.E.W., Rosen L.S., Vokes E.E., Kies M.S., Forastiere A.A., Worden F.P., Kane M.A., Sherman E., Kim S., Bycott P., Tortorici M., Shalinsky D.R., Liau K.F., Cohen R.B. Axitinib is an active treatment for all histologic subtypes of advanced thyroid cancer: results from a phase II study. J. Clin. Oncol. 2008, 26:4708-4713.
4. Kelly R.J., Rixe O. Axitinib (AG-013736). Small Molecules in Oncology, Recent Results in Cancer Research 2010, vol. 184:33-44. Springer-Verlag, Berlin.
5. O'Donnell R.M., Sun X., Harrington P.B. Pharmaceutical applications of ion mobility spectrometry. Trends Anal. Chem. 2008, 27:44-53.
6. Steiner R.R., Larson R.L. Validation of the direct analysis in real time source for use in forensic drug screening. J. Forensic Sci. 2009, 54:617-622.
7. Cody R.B., Laramée J.A., Durst H.D. Versatile new ion source for the analysis of materials in open air under ambient conditions. Anal. Chem. 2005, 77:2297-2302.
8. Kanu A.B., Hill H.H. Identity confirmation of drugs and explosives in ion mobility spectrometry using a secondary drift gas. Talanta 2007, 73:692-699.
9. Mäkinen M.A., Anttalainen O.A., Sillanpää M.E.T. Ion mobility spectrometry and its applications in detection of chemical warfare agents. Anal. Chem. 2010, 82:9594-9600.
10. Nilles J.M., Connell T.R., Durst H.D. Quantitation of chemical warfare agents using the direct analysis in real time (DART) technique. Anal. Chem. 2009, 81:6744-6749.
11. Fernández F.M., Hampton C.Y., Nyadong L., Navare A., Kwasnik M. Liquid chromatography and ambient ionization time-of-flight mass spectrometry for the analysis of genuine and counterfeit pharmaceuticals. Liquid Chromatography Time-of-Flight Mass Spectrometry: Principles, Tools, and Applications for Accurate Mass Analysis 2009, 113-132. Wiley, Hoboken, NJ. I. Ferrer, E.M. Thurman (Eds.).
12. Dunn J.D., Gryniewicz-Ruzicka C.M., Kauffman J.F., Westenberger B.J., Buhse L.F. Using a portable ion mobility spectrometer to screen dietary supplements for sibutramine. J. Pharm. Biomed. Anal. 2011, 54:469-474.
13. Gryniewicz C.M., Reepmeyer J.C., Kauffman J.F., Buhse L.F. Detection of undeclared erectile dysfunction drugs and analogues in dietary supplements by ion mobility spectrometry. J. Pharm. Biomed. Anal. 2009, 49:601-606.
14. Peterson D.E., Eden G.C., Apodaca C.R., Argyres D.P., Kennedy A.L., Barnhill J.G., Felton L.A. Ion mobility spectrometry for determination of active drug in blinded dosage forms. AAPS Newsmagazine 2005, 18-19. http://www.aapspharmaceutica.com/publications/newsmagazine/2005/feb05/default.asp, (accessed 11.02.11).
15. Borsdorf H., Eiceman G.A. Ion mobility spectrometry: principles and applications. Appl. Spectrosc. Rev. 2006, 41:323-375.
16. Eiceman G.A., Karpas Z. Ion Mobility Spectrometry 2005, CRC Press, Boca Raton, FL. second ed.
17. Laramee J.A., Cody R.B. Chemi-ionization and direct analysis in real time (DART™) mass spectrometry. The Encyclopedia of Mass Spectrometry 2007, vol. 6:377-387. Elsevier, Amsterdam.
18. S. Bender, D.J. Skalitzky, D. Hu-Lowe, Indazole compounds and pharmaceutical compositions for inhibiting protein kinases, and methods for their use, U.S. Pat. Appl. Pub., U.S. 2005/0038097 A1, February 17, 2005.
19. Song L., Gibson S.C., Bhandari D., Cook K.D., Bartmess J.E. Ionization mechanism of positive-ion direct analysis in real time: a transient microenvironment concept. Anal. Chem. 2009, 81:10080-10088.
20. R.A. Singer, manuscript in preparation.
21. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q3B(R2) Impurities in New Drug Products 2006, http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html, (accessed 11.02.11).