Two selective HPLC methods with UV detection were developed to analyse cilostazol and its related substances. Due to great difference between spectral properties of the analytes,  the analysis was divided into two independent parts. Separation of cilostazol and its potential impurities was achieved on Kinetex C18 chromatographic column (100 mm x 4.6 mm x 2.6 μm) by gradient elution with ammonium acetate buffer and acetonitrile. Chromatograms were acquired at 254 nm. The second method for the quantitative determination of CX-1 (starting material in the synthetic route) assay was investigated on Synergi MAX-RP chromatographic column (150 mm x 4.6 mm x 4 μm) with the use of H₂O:CH₃CN (1:1, v/v) mixture and isocratic elution. Detection was carried out at 193 nm.

Both methods were validated for linearity, specificity, precision, accuracy, limit of detection, limit of quantification and robustness. Suitability of HPLC methods for the pharmaceutical control of cilostazol samples and the validation according to requirements of Q2(R1) International Conference of Harmonization scientific guideline were demonstrated.

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