Ecofriendly chromatographic method for the separation and quantification of vonoprazan fumarate, a novel potassium competitive acid blocker with amoxicillin and clarithromycin which are effective in the treatment of Helicobacter pylori

This work developed and validated a new UV-HPLC method for the separation and quantification of vonoprazan fumarate (VNP), amoxicillin (AMX), and clarithromycin (CLM), together in a ternary mixture and in laboratory-prepared tablets. A C18 column and a delightful 70:30 blend of 0.05 M KH2PO4 buffer pH 6 and acetonitrile were used as mobile phase. The flow rate was 1.5 mL min⁻¹, while the wavelength of detection was 254 nm. Linear concentration ranges of (1.0–10.0 μg mL⁻¹) vonoprazan fumarate, (1.0–125.0 μg mL⁻¹) amoxicillin, and (25.0–1,200 μg mL⁻¹) clarithromycin resulted in 0.061, 0.6213, and 7.302 μg mL⁻¹ detection levels and 0.1849, 0.845, and 22.127 μg mL⁻¹ quantification values for VNP, AMX, and CLM, respectively. The greenness of this method was evaluated using the National Environmental Methods Index assessment (NEMI), analytical Eco-scale Assessment (ESA) tool, Green Analytical Procedure Index assessment (GAPI), and Analytical Greenness metric assessment (AGREE), which authenticated the method to be eco-friendly. This method, which was systematically validated and used also to calculate the concentration of the three drugs in their dosage forms, showed high accuracy and precision. Additionally, it produced peaks that were clearly separated and resolved, demonstrating its robustness and specificity.