Hplc study of Cilostazol tablets: assay and release profile determination

Marta Majewska ,  Edyta Pesta ,  Michał Tynderynda ,  Katarzyna Badowska-Rosłonek ,  Magdalena Kossykowska ,  Anna Ostaszewska 

Pharmaceutical Research Institute, Rydygiera 8, Warsaw 01-793, Poland

Abstract

The aim of this work was to develop analytical methods for studying cilostazol tablets. Cilostazol is an antithrombotic drug, used to extend painless walking in intermittent claudication.Medium recommended for FDA didn’t produce good results for the release profile Cilostazol tablets [1]. A method for the release profile determination was developed using 0.5% sodium dodecylsulphate in water as the medium (900 mL volumes, rotations at 50/min). The active substance was released by the spatula method. The obtained release profiles were similar to the profiles of the reference product (Pletal 50 mg and Pletal 100 mg purchased from Brecon Pharmaceuticals Ltd.). Over 80% of the active substance was released after 15 min in both 50 mg and 100 mg tablets obtained in the Pharmaceutical Research Institute. A repeatable HPLC method for the API assay in tablets was developed. The method is characterized by short analysis time, about 9 minutes. For the purity study, a method was developed which was characterized by good HPLC parameters: high separation, favorable peak symmetry, numerous theoretical plates. The developed methods are in accordance with the Pharmacopea’s [3] requirements regarding HPLC methods.

References:

[1] Food and Drug Administration, Dissolution Methods

[2] Theapeutic Advances in Cardiovascular Disease 2012, 6: 53-70

[3] Pharmacopoeia Polonica,, Editio IX, 2.9.3. 351

 

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Presentation: Poster at IX Multidyscyplinarna Konferencja Nauki o Leku, by Marta Majewska
See On-line Journal of IX Multidyscyplinarna Konferencja Nauki o Leku

Submitted: 2014-03-23 20:12
Revised:   2014-05-02 12:47