A novel, precise, accurate and rapid isocratic reversed-phase high performance liquid chromatographic/ultraviolet (RP-HPLC/UV) method was developed, optimized and validated for simultaneous determination of Febuxostat and Diclofenac potassium. Effect of different experimental parameters and various particulate columns on the analysis of these analytes was evaluated. The method showed adequate separation for Febuxostat and Diclofenac potassium and best resolution was achieved with Enable analytical C18, (250 mm × 4.6 mm × 5 μm) using acetonitrile-methanol-water (30:30:40, v/v; pH adjusted to 5.0 with TEA and o-phosphoric acid) as a mobile phase at a flow rate of 1 ml/min and wavelength of 280 nm. The calibration curves were linear over the concentration ranges of 4-24 μg/ml for Febuxostat and 10-60 μg/ml for Diclofenac potassium. The limit of detection (LOD) and limit of quantification (LOQ) for Febuxostat were 0.389 and 1.18 μg/ml while for Diclofenac potassium were 0.843 and 2.557 μg/ml, respectively. All the analytes were separated in less than 6.0 min. The proposed method could be applied for routine laboratory analysis of Febuxostat and Diclofenac potassium in pharmaceutical dosage form.
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