The present study describes the development and validation of a stability indicating reverse phase HPLC (RPHPLC) method for the analysis of lafutidine, an H2 receptor antagonist drug, in tablet dosage forms. The proposed RP-HPLC method utilizes Shisheido C18, 250mm x 4.6mm, 5μm column (at ambient temperature), isocratic run (using methanol and acetonitrile as mobile phase), at a flow rate of 1.0 ml/minute, and UV detection at 273nm for analysis of lafutidine. The reported method is linear over the range of 75-200μg/ml. The precision, ruggedness and robustness values were also within the prescribed limits. Lafutidine was exposed to acidic, alkaline, oxidative, thermal and photolytic stress conditions- and the stressed samples were analyzed by the proposed method. Chromatographic peak purity results indicated the absence of co-eluting peaks with the drug peak, which demonstrated the specificity of assay method for estimation of lafutidine in presence of degradation products. The proposed method can be used for routine analysis stability testing of lafutidine in quality control laboratories.
