Volume 3

April-June 2011

Validation and optimization of a simple RP-HPLC method for determination of cilostazol in human serum

Jafreen Jamal Joti, Md Ahsanul Haque, S M Ashraful Islam, Mohammad Safiqul Islam

Abstract:
Cilostazol is a synthetic antiplatelet and vasodilator agent. In the present study, a simple, sensitive and specific liquid chromatography (HPLC) method with UV detection was developed and validated for the quantification of cilostazol in human serum samples using diazepam as internal standard. The mobile phase consisted of water and acetronitrile (60:40%, V/V), pumped at a flow rate of 1.0 ml/min through the C-18 column at room temperature. Chromatographic separation was accompanied at 254 nm with a sensitivity of 0.0001. The developed method was selective and linear for cilostazol concentrations ranged in between 20 to 2000ng/ml for serum samples. The recovery of cilostazol ranged from 96.35 to 112.68%. The limit of quantitation (LOQ) of cilostazol was 20 ng/ml. The intraday accuracy ranged from 115.50% to 119.52%, the interday accuracy varied from 99.22 to 103.06%. For the LOQ, good values of precision (1.820 and 2.02% for intraday and interday, respectively) are also obtained. Acceptable results were obtained during stability study. This method proved to be simple, accurate and precise and can be used for pharmacokinetic and bioequivalence studies of cilostazol.

Keywords: Cilostazol, Method Validation, HPLC, Pharmacokinetic.