Abstract
Abstract 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 mm × 100 mm, 1.7 μm) 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.
Highlights
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
Lafutidine belongs to the class of H2-receptor antagonists and is used in the treatment of peptic ulcer and gastro-esophageal reflux disease or GERD [1]
Diammonium hydrogen orthophosphate of high performance liquid chromatography (HPLC) grade and liquid ammonia of AR grade were purchased from Merck, Mumbai, India
Summary
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. Lafutidine belongs to the class of H2-receptor antagonists and is used in the treatment of peptic ulcer and gastro-esophageal reflux disease or GERD [1]. It is available in the market under the brand name LafaxidW in the form of tablets for oral administration containing 5 or 10 mg of lafutidine with daily dose of 5 to 10 mg twice daily [2]. It has gastroprotective activity that affects the mucosal blood flow. It elevates the postprandial intragastric pH and increases plasma calcitonin gene-related peptide and somatostatin concentrations in humans. It is proven that lafutidine is equal or superior to conventional H2 antagonists in antiulcer potency and it is
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