A simple, specific, accurate and stability-indicating high performance liquid chromatographic method for determination of lafutidine, using Hypersil BDS C18 (250 x 4.6 mm, i.d., 5 µm) column and a mobile phase comprising of methanol and 0.05 M ammonium acetate in a ratio of 45:55 (v/v). The retention time of lafutidine was 9.0 min. The linearity was established in the range of 100-600 µg/ml. The percentage recoveries for lafutidine were in the range of 100.4045±0.0392 - 101.5068±0.5846. The drug was subjected to acid, alkaline, photolytic, oxidative, neutral hydrolysis and thermal degradation. The degradation studies indicated, lafutidine was susceptible towards acid, alkaline, photolytic and oxidative hydrolysis and was comparatively stable towards neutral and thermal stress. The degradation products of lafutidine were well resolved from the pure drug with significant differences in their retention time values. The method can be successfully employed for determination of lafutidine in bulk drug and also for characterization of degradation products as it is stability-indicating one.
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