A validated stability indicating high performance reverse phase liquid chromatographic method for the determination of cilostazol in bulk drug substance.

ABSTRACT

A simple, rapid and accurate reverse phase high-performance liquid chromatographic (RP-HPLC) method was developed for the quantitative determination of cilostazol. The developed method is also applicable for the related substance determination in bulk drugs. The chromatographic separation was achieved on reversed-phase C-18 column. Eluents were monitored on photo-diode array detector at a wavelength of 210 nm using a mixture (5050) of water and acetonitrile. Solution concentrations were quantified by external calibration. In the developed HPLC method, resolution between cilostazol and its potential impurities, namely Imp-A, Imp-B, and Imp-C were found greater than two. The drug was subjected to stress condition of hydrolysis, oxidation, photolysis and thermal degradation. Considerable degradation was found to occur in alkaline medium stress condition. The developed RP-HPLC method was validated with respect to linearity, accuracy, precision, stability of analytical solutions, and robustness.