Development and validation of stability indicating assay method for the estimation of lafutidine and domperidone in capsule dosage form

A simple, sensitive, precise and specific high performance liquid chromatography method was developed and validated for the determination of Lafutidine and Domperidone in Lafutidine and Domperidone sustained release capsule. The separation was carried out by using a mobile phase consisting Acetonitrile: pH 6.5 phosphate buffer in ratio of 30: 70. The column used was Xterra 250mm X 4.6mm, 5μ with flow rate 1 ml/min using UV detection at 276 nm. The retention time of Lafutidine and Domperidone were found to be 7.0 and 15.5 min respectively. Degradation study of Lafutidine and Domperidone in its capsule form was conducted under condition of hydrolysis, oxidation, thermal and photolysis, the results of analysis were validated statistically and by recovery studies (mean recovery = 99.94). The result of study showed that the proposed method is simple, rapid, precise and accurate, which is useful for the routine determination of Lafutidine and Domperidone in pharmaceutical dosage form.