DEVELOPMENT AND VALIDATION OF A GREEN STABILITY-INDICATING RP-HPLC METHOD FOR VONOPRAZAN FUMARATE WITH AGREE-BASED GREENNESS ASSESSMENT

Aim: The present study aimed to develop and validate a simple, rapid, accurate, precise, stability-indicating, and environmentally friendly RP-HPLC method for the quantitative estimation of Vonoprazan Fumarate (VPZ) in pharmaceutical dosage forms and to evaluate its greenness using AGREE-based assessment tools. Study Design: Experimental analytical method development and validation study based on ICH guidelines. Place and Duration of Study: Department of Pharmaceutical Chemistry and Department of Pharmaceutical Analysis, Delonix Society’s Baramati College of Pharmacy, Maharashtra, India. The study was carried out during the academic research period of 2025–2026. Methodology: Chromatographic separation was performed on C18 column (250 × 4.6 mm, 5 µm) with an isocratic mobile phase of methanol and aqueous phase containing 1% HCl (70:30 v/v) at a flow rate of 1.0 mL/min. Detection was carried out at 268 nm. The developed method was validated for specificity, linearity, accuracy, precision, robustness, ruggedness, limit of detection (LOD) and limit of quantification (LOQ) as per ICH requirements. Forced degradation studies were performed under acid, base, oxidative, thermal and photolytic stress conditions to assess the method’s ability to indicate stability. AGREE and AGREEprep metrics were used to assess greenness. Results: The technique showed a clear symmetric peak at about 3.3 min retention time. The method showed good linearity over the concentration range of 5–25 µg/mL with a correlation coefficient (r2) of 0.9991. The recoveries were in the range 98% to 102% as per accuracy surveys. %RSD readings for intra-day and inter-day precision were 0.63% and 0.98%, respectively. The results revealed that the LOD and LOQ were 1.58µg/mL and 5.220 µg/mL, respectively. Robustness and ruggedness studies gave acceptable values of %RSD below 2%. The specificity and stability-indicating nature of the method was proved by forced degradation studies. The greenness assessment results were 0.73 and 0.62 for AGREE and AGREEprep, respectively. Conclusion: The developed RP-HPLC method is simple, precise, accurate, stability-indicating, and environmentally sustainable, making it suitable for routine quality control analysis of Vonoprazan Fumarate in pharmaceutical formulations.