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Physicochemical characterization of sunitinib and its impurities

Katarzyna Sidoryk 1Krzysztof Bańkowski 1Marek Kubiszewski 1Marta Łaszcz 1Magdalena Bodziachowska-Panfil 1Magdalena Kossykowska 1Maura Maliska 2Krzysztof Woźniak 2

1. Pharmaceutical Research Institute, Rydygiera 8, Warsaw 01-793, Poland
2. Structural Research Laboratory, the University of Warsaw Chemistry Department, Żwirki i Wigury 101, Warsaw 02-089, Poland


    Sunitinib is an oral small-molecule tyrosine kinase inhibitor (TKI) that targets and blocks the signaling pathways of multiple selected receptor tyrosine kinases (RTKs). Sunitinib was approved by the FDA for the treatment of renal cell carcinoma (RCC) and imatinib-resistant gastrointestinal stromal tumor (GITS) on January 26, 2006.

    During the investigation on the synthesis of pharmaceutically pure sunitinib L-malate based on the procedure described in EP 1255752B1 (Sugen Inc. and Pharmacia & Upjohn Co.) the physicochemical studies of sunitinib as well as its potential degradation products and process-related impurities were performed. The structure elucidation of the compounds was accomplished by means of the following techniques: NMR, IR and MS. Furthermore, X-ray single-cristal studies of sunitinib unambiguously proved the structure. A selective HPLC method for the determination of chemical purity of sunitinib was applied.


Research Project is supported by European Union, Project no UDA-POIG.01.03.01-14-069/08-00, 26.02.2009„Innovative technologies of oncological medicines of special therapeutic and social importance”.


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Presentation: Poster at VIII Multidyscyplinarna Konferencja Nauki o Leku, by Krzysztof Bańkowski
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Submitted: 2012-03-14 10:56
Revised:   2012-03-20 12:34