AQBD ASSISTED DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR THE DETERMINATION OF FEXUPRAZAN HYDROCHLORIDE IN ITS TABLET DOSAGE FORM

Dr. Vidhi Kotadiya*, Dr. Avani Doshi, Ruchita Mistry

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.

Keywords: Method Development, Validation, AQBD, Robust.