Integrated Design of Experiments Approach for a Stability-indicating Rp-hplc Method of Fexuprazan Hydrochloride
Abstract
Abstract Background Fexuprazan hydrochloride is a novel potassium-competitive acid blocker requiring reliable analytical methods for quality and stability evaluation. Aim To develop and validate a rapid, robust, and stability-indicating RP-HPLC method using a Design of Experiments (DoE) approach. Methods Separation was achieved on a C18 column using Methanol: phosphate buffer (70:30, pH 3.5) at 1.0 mL/min with detection at 256 nm. Central Composite Design (CCD) was applied for optimization. Validation was performed as per ICH guidelines, and forced degradation studies were conducted. Results and Discussion The method showed a retention time of ~ 4.5 min with good peak symmetry and no interference. Linearity was observed over 10–60 µg/mL (R² = 0.998). Accuracy (99.54–99.75%) and precision (%RSD Conclusion The developed RP-HPLC method is simple, precise, and reliable, suitable for routine quality control and stability analysis of fexuprazan hydrochloride.
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