DEVELOPMENT AND VALIDATION OF A ROBUST RP-HPLC METHOD FOR QUANTIFICATION OF VONOPRAZAN FUMARATE IN PHARMACEUTICAL DOSAGE FORMS AND HUMAN PLASMA

Abstract

Background: Vonoprazan Fumarate is a potassium-competitive acid blocker (P-CAB) that inhibits gastric H⁺, K⁺ ATPase, effectively reducing acid secretion and treating disorders such as Gastroesophageal Reflux Disease and Helicobacter pylori infection. Objective: This study aimed to develop and validate a simple, sensitive, and cost-effective RP-HPLC method for quantifying Vonoprazan Fumarate in human plasma. Materials & Methods: Chromatographic separation was achieved on an Agilent C18 column (150 × 4.6 mm, 5 μm) with a mobile phase of methanol and 0.1% acetic acid in water (50:50 v/v) at a flow rate of 0.7 mL/min. Detection was carried out at 225 nm. Plasma samples were prepared using acetonitrile-induced protein precipitation. Method validation was performed as per International Council for Harmonisation guidelines. Results: The method showed a retention time of 10 min with good peak symmetry. Linearity was observed over 2–10 μg/mL (r² ≥ 0.999). LOD and LOQ were 0.5140 μg/mL and 1.5577 μg/mL, respectively. The recovery was 98.66%, with %RSD <2%, confirming accuracy and precision. Conclusion: The validated RP-HPLC method is reliable and suitable for routine plasma analysis and pharmacokinetic studies of Vonoprazan Fumarate.