Aqbd assisted development and validation of stability indicating RP-hplc method for the determination of fexuprazan hydrochloride in its tablet dosage form
Abstract
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 99.54%. Furthermore, the Quality by Design (QbD) approach enabled systematic optimization of chromatographic conditions, resulting in a robust and reliable method suitable for routine analysis of Fexuprazan Hydrochloride.
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