Identification of degradation products of cilostazol drug substance
|Magdalena Kossykowska , Marta Zezula , Joanna Zagrodzka , Katarzyna Badowska-Rosłonek|
Pharmaceutical Research Institute (IF), Rydygiera 8, Warszawa 01-793, Poland
Cilostazol, 6-[4-(1-cyclohexyl-1H-tetrazol-5-yl)butoxy]-3,4-dihydro-2(1H)-quinolinone, is used to improve the symptoms of blood flow problem in the legs (intermittent claudication). Cilostazol can increase blood flow and the amount of oxygen that gets to the muscles. It works by preventing platelets blood from sticking together and by widening blood vessels in the legs. This helps the blood to move more easily and increases blood flow .
The crude cilostazol obtained using the synthetic route developed in PRI contains four main impurities. The impurities were identified. Additionally, stress testing studies were performed to determine the stability of the drug substance under different conditions (neutral, acidic, basic hydrolysis and oxidative degradation) and identify the main degradation products. Attempts to make structural assignment of these compounds by HPLC-MS-MS was the main assumption of this work. Based on the HPLC-MS-MS analyses the potential structures of the degradation products were proposed.
Presentation: Poster at IX Multidyscyplinarna Konferencja Nauki o Leku, by Magdalena Kossykowska
See On-line Journal of IX Multidyscyplinarna Konferencja Nauki o Leku
Submitted: 2014-03-13 08:45 Revised: 2014-05-02 11:48