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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 [1].

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.

The study was supported by European Union under European Regional Development Fund No. UDA-POiG.01.03.01-14-062/09-00 “Innovative technologies of cardiovascular medicines of special therapeutic and social importance”.

[1] Note for guidance on clinical investigation of medicinal products for the treatment of peripheral arterial occlusive disease. Committee for proprietary Medical Products. The European Agency for the Evaluation of Medical Products.


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Submitted: 2014-03-13 08:45
Revised:   2014-05-02 11:48