Development and validation of stability-indicating UPLC method for the determination of lafutidine and its impurities in bulk and pharmaceutical dosage form

Background: A simple and rapid stability-indicating, reversed phase ultra-performance liquid chromatography (UPLC) method was developed for the quantitative determination of lafutidine and its four potential impurities. Results: Separation was achieved on Acquity BEH-shield RP18 UPLC column (3.0 mmx 100 mm, 1.7 mu m) under the gradient mode of elution by using mobile phase A (0.02M diammonium hydrogen phosphate/acetonitrile, 80: 20 v/v) and mobile phase B (0.02M diammonium hydrogen phosphate/acetonitrile, 30: 70 v/v). The flow rate was maintained at 0.5 mL min(-1). UV detection was carried out at 276 nm. Conclusions: Stability-indicating capability of the developed method is established by analyzing forced degradation samples in which the spectral purity of lafutidine is ascertained along with the separation of degradation products from analyte peak. The developed UPLC method is validated as per International Conference on Harmonization guidelines with respect to system suitability, specificity, precision, sensitivity, accuracy, linearity, and robustness.