Development and Validation of a UV-Visible Spectrophotometric Method for Vonoprazan Using a Green Approach

This study aimed to develop a novel, rapid, and precise UV spectrophotometric method for quantifying Vonoprazan in both pure and tablet dosage forms. On the basis of an extensive evaluation of solubility, stability, toxicity, and carcinogenicity, and in line with eco-friendly approaches, a mixed phosphate buffer solution (pH 6.8) was employed as the solvent. Spectrophotometric analysis was performed within the 200–400 nm wavelength range. A distinct absorption maximum was identified at 237 nm, and strong linear relationship (r = 0.998) was observed, indicating compliance with Beer’s law within the 10–30 μg/mL concentration range. Furthermore, the recovery of Vonoprazan ranged from 98.01 to 101.25% (w/w), confirming the method’s accuracy. Precision of the method was confirmed by the percentage relative standard deviation, which remained within acceptable limits as per guidelines. Compliance with the stringent requirements of ICH Q2 (R1) was ensured throughout the entire evaluation process. Assessment of the method’s greenness was carried out using the Analytical Eco-Scale, AGREE metrics, and GAPI. Findings from the greenness evaluation and analytical merits confirmed the method’s reliability and supported its suitability as an improved alternative for Vonoprazan analysis.

1. Garnock-Jones, P. Karly, Drugs, 75, 439–443 (2015).

2. H. Echizen, Clin. Pharmacokinetics, 55, 409–418 (2016).

3. Ahmed M. Saleh, Amira M. El-Kosasy, Nermine V. Fares, Egypt. J. Chem., 66, 141–148 (2023).

4. Ahmed H. Abdelazim, Ashraf Abdel-Fattah, Ayman O. E. Osman, Rady F. Abdel-Kareem, Sherif Ramzy, J. AOAC Int., 106, 490–495 (2023).

5. A. M. Ali Noha, M.A. Alaa El-Din, Mary Elias Kamel Wahba, Aziza E. Mostafa, Acta Chromatographica, 37, 559–571 (2025).

6. Mona M. Abdel Moneim, Mohamed M. A. Hamdy, BMC Chem., 18, 230 (2024).

7. Yomna A. Salem, Samah A. Elsabour, Amal A. El-Masry, BMC Chem., 18, 111 (2024).

8. P. Kanaga, Int. J. Pharm. Sci., 2, 323–331 (2024).

9. Nader Mohamed Alzaghai, El-Sayed H.El-Mossalamy, Gamal O. El-Sayed, Egypt. J. Chem, 67, 145–159 (2024).

10. Hoda Mahgoub., Marwa A.A. Ragab, Salma Tarek, Hadir M. Maher, BMC Chem., 18, 106 (2024).

11. Charumathi Salva, Rajitha Galla, J. Appl. Pharm. Sci., 14, 193–202 (2024).

12. A. Galuszka, Z. M. Migaszewski, P. Konieczka, TrAC – Trends Anal. Chem., 37, 61–72 (2012).

13. J. Plotka-Wasylka, Talanta, 181, 204–209 (2018).

14. F. Pena-Pereira, W. Wojnowski, M. Tobiszewski, Anal. Chem., 92, 10076–10082 (2020).