Green Analytical Stability Indicating UHPLC Method for the Quantification of Related Impurities in Vonoprazan Formulation Applying Analytical Quality by Design

ABSTRACT Vonoprazan is an innovative potassium competitive acid blocker and has emerged as an effective alternative to proton pump inhibitors for the treatment of acid‐related disorders. High‐performance liquid chromatography was performed using a Symmetry C18 column (150 mm × 4.6 mm ID, 3.0 µm) with a mobile phase flow rate of 1.0 mL/min. Mobile phase A consisted of ammonium formate, pH adjusted to 3.0 and mobile phase B was ethanol. The analysis employed a gradient elution method. This method was used for the quantification of degradant impurities, including impurity A and impurity C, originating from vonoprazan. The accuracy results demonstrated that the results for impurities A and C ranged from 100.6% to 102.6%. Additionally, the sample solution was confirmed to remain stable under all evaluated conditions for up to 24 h. Using analytical quality by design principles and design expert software, method robustness was assessed in terms of mobile phase flow rate, column temperature, and mobile phase buffer pH variability. Moreover, the method was assessed for environmentally sustainable behavior using the analytical eco‐scale evaluations, analytical greenness, and green analytical procedure index.