Bioanalytical Method Development and Validation For The Estimation of Fexuprazan Hcl in Marketed Formulations

Abstract

The present study was undertaken for the development and validation of an RP-HPLC method for the quantitative estimation of Fexuprazan HCl and its application to the analysis of marketed tablet formulation. The work included preformulation characterization of the drug, optimization of chromatographic conditions, preparation of standard and sample solutions, and evaluation of important analytical method validation parameters. Fexuprazan Hydrochloride, a novel potassium-competitive acid blocker, requires a reliable analytical method for quality control. In the present study, a simple, accurate, precise, and stability-indicating RP-HPLC method was successfully developed and validated s per ICH guidelines. The method demonstrated excellent linearity (R² = 0.999), satisfactory precision, high accuracy (100.02–100.06% recovery), and good sensitivity. The assay of the marketed formulation was found to be 99.60%.