Abstract

A new simple rapid, isocratic, and stability-indicating reverse phase high performance liquid chromatography technique was developed for the quantification of Ifetroban. Optimization was achieved with Zorbax SB C18 (250×4.6 mm, 5 μ) and mobile phase comprising of 0.1 mM phosphate buffer (pH 3.0±0.05):acetonitrile (65:35 % v/v). The mobile phase was pumped at a flow rate of 1.0 ml/min and analysis was performed with a photodiode array detector. The method was validated as per International Council for Harmonisation guidelines with respect to precision, linearity, accuracy, ruggedness and specificity. The drug is exposed to various degradation conditions like acidic and basic hydrolysis, oxidation, and exposure to ultra-violet light and temperature (dry heat) and the degraded samples were analyzed by the developed method. No co-eluting degradants or interfering peaks were observed during stress conditions and all the degradants were resolved from the main peak.