Author(s):
Manasvi M. Sonavane, Sunila A. Patil, Sunil P. Pawar
Email(s):
manusonavane2002@gmail.com
DOI:
10.52711/2231-5675.2026.00049 
Address:
Manasvi M. Sonavane1*, Sunila A. Patil2, Sunil P. Pawar3
1P.S.G.V.P.M’s College of Pharmacy, Shahada, Dist - Nandurbar. Kavayitri Bahinabai Chaudhari North Maharashtra University, Jalgaon, Maharashtra, India.
2Associate Professor, P.S.G.V.P.M’s College of Pharmacy, Shahada, Dist - Nandurbar. Kavayitri Bahinabai Chaudhari North Maharashtra University, Jalgaon, Maharashtra, India.
3Principal, P.S.G.V.P.M’s College of Pharmacy, Shahada, Dist - Nandurbar. Kavayitri Bahinabai Chaudhari North Maharashtra University, Jalgaon, Maharashtra, India.
*Corresponding Author
Published In:
Volume - 16,
Issue - 4,
Year - 2026
ABSTRACT:
Vonoprazan fumarate is a novel potassium-competitive acid blocker (P-CAB). It is used for the treatment of acid related diseases such as gastro-esophageal reflux disease (GERD), peptic ulcer disease and eradication of Helicobacter pylori. It works by blocking potassium binding site of H+K+-ATPase enzyme and decreases gastric acid production. It has faster onset of action and gives prolonged acid suppression. Due to its increasing therapeutic importance, reliable analytical techniques are required for its quantitative estimation in pharmaceutical dosage forms and biological samples. Among the available analytical techniques, reverse phase high-performance liquid chromatography (RP-HPLC) has gained considerable attention because of its sensitivity, accuracy, and reproducibility. The present review summarizes the drug description and analytical methods reported for the determination of vonoprazan fumarate in bulk and pharmaceutical dosage form with particular emphasis on RP-HPLC techniques. Different chromatographic techniques such as UV-Visible spectroscopy, High-Performance Liquid Chromatography (HPLC), Reverse Phase High-Performance Liquid Chromatography (RP-HPLC), Ultra Performance Liquid Chromatography (UPLC), and High-Performance Thin Layer Chromatography (HPTLC) are discussed. Analytical method validation parameters in accordance with ICH guidelines described in the literature are discussed.
Cite this article:
Manasvi M. Sonavane, Sunila A. Patil, Sunil P. Pawar. A Review on Analytical Method Development and Validation for Estimation of Vonoprazan Fumarate by RP-HPLC Method in Bulk and Tablet Dosage Form. Asian Journal of Pharmaceutical Analysis. 2026; 16(4):318-4. doi: 10.52711/2231-5675.2026.00049
Cite(Electronic):
Manasvi M. Sonavane, Sunila A. Patil, Sunil P. Pawar. A Review on Analytical Method Development and Validation for Estimation of Vonoprazan Fumarate by RP-HPLC Method in Bulk and Tablet Dosage Form. Asian Journal of Pharmaceutical Analysis. 2026; 16(4):318-4. doi: 10.52711/2231-5675.2026.00049 Available on: https://www.ajpaonline.com/AbstractView.aspx?PID=2026-16-4-11
REFERENCES:
1. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215151s000lbl.
2. Gauri N. Rajage, Vaishali B. Jadhav, Dr. Ashish Jain, Dr. Reshma V. Jadhav, Saiesh Jogdandkar, Preeti B. Ghule, Manasi S. Mahadik, and Rupali C. Bothara. (2024). Green Assessment-Based Stability-Indicating Rp-Hplc Method Development and Validation for the Determination of Vonoprazan Fumarate in Bulk and Formulations. Revista Electronica De Veterinaria, 25(2), 1436 -1445. https://doi.org/10.69980/redvet.v25i2.1831.
3. Moneim MMA, Hamdy MMA. Chromatographic assay of recently approved co-formulation of Vonoprazan fumarate with low dose Aspirin: AGREE, Complex MoGAPI, and RGB 12-model assessments. BMC Chem. 2024 Nov 16;18(1):230. doi: 10.1186/s13065-024-01344-7. PMID: 39548471; PMCID: PMC11568669.
4. Jenkins H, Sakurai Y, Nishimura A, et al. Randomised clinical trial: safety, tolerability, pharmacokinetics and pharmacodynamics of repeated doses of TAK-438 (vonoprazan), a novel potassium-competitive acid blocker, in healthy male subjects. Aliment Pharmacol Ther. 2015;41(7):636–48
5. Skoog DA, Holler FJ, Crouch SR. Principles of Instrumental Analysis. 6th ed. Boston: Cengage Learning; 2014.
6. International Conference on Harmonization (ICH), Validation of analytical procedure: Text and methodology, Harmonized tripartite guideline, Q2 (R1), Geneva, 2005.
7. www.fda.gov/medwatch.
8. NIH (National center for advancing translational and Sciences), “vonoprazan fumarate,” Inxight Drugs. https://drugs.ncats.io/drug/4QW3X4AMLB#substancescar
9. Pubchem, “Compound-Summary-(Vonoprazan fumarate).” https://pubchem.ncbi.nlm.nih.gov/compound/45375887
10. Wong N, Reddy A, Patel A. Potassium-Competitive Acid Blockers: Present and Potential Utility in the Armamentarium for Acid Peptic Disorders. Gastroenterol Hepatol (N Y). 2022 Dec;18(12):693-700. PMID: 36865588; PMCID: PMC9972603.
11. St Onge E, Phillips B. Vonoprazan: A New Potassium-Competitive Acid Blocker. J Pharm Technol. 2023 Jun;39(3):139-146. doi: 0.1177/87551225231166531.
12. Vinayagam S, Mittal N, Kaushal J. Vonoprazan: a promising advancement in proton pump inhibitor therapy. International Journal of Basic and Clinical Pharmacology, 2024; 13(4), 573-579 https://doi.org/10.18203/2319-2003.
13. Phathom Pharmaceuticals Inc. Voquezna (vonoprazan) tablets: US prescribing information. 2023. https://www.phathompharma.com/wp-content/uploads/VOQUEZNA-tablets-Prescriber-Information.pdf. Accessed 19 Dec 2023.
14. Shirley, Matt 2024. Vonoprazan: A Review in Helicobacter pylori Infection. Drugs 84:319-327 doi-10.1007/s40265-023-01991-5.
15. Sugano K. Vonoprazan fumarate, a novel potassium-competitive acid blocker, in the management of gastroesophageal reflux disease: safety and clinical evidence to date. Therap Adv Gastroenterol. 2018 Jan 9;11: doi: 10.1177/1756283X17745776.
16. Shin JM, Inatomi N, Munson K, et al. Characterization of a novel potassium-competitive acid blocker of the gastric H, K-ATPase, 1-[5-(2-fluorophenyl)-1-(pyridine-3-ylsulfony)-1H-pyrrol-3-yl]-N-methyl methanamine fumarate (TAK-438). J Pharmacol Exp Therap 2011; 339: 412–420.
17. Sampath S., and Elavarasan V. (2024). RP-HPLC Method Development and Validation for Simultaneous Estimation of Amoxicillin, Clarithromycin and Vonoprazan in Tablets. Journal of Emerging Technologies and Innovative Research (JETIR), 11(4), g500-g508.
18. Echizen, H. (2016). The first-in-class potassium-competitive acid blocker, vonoprazan fumarate: Pharmacokinetic and pharmacodynamic considerations. Clinical Pharmacokinetics, 55(4), 409–418. https://doi.org/10.1007/s40262-015-0328-7.
19. Yang E, Ji SC, Jang IJ, Lee S. Evaluation of CYP2C19-Mediated Pharmacokinetic Drug Interaction of Tegoprazan, Compared with Vonoprazan or Esomeprazole. Clin Pharmacokinet. 2023;62(4):599-608.
20. Hori, Y., Imanishi, A., Matsukawa, J., Tsukimi, Y., Nishida, H., Arikawa, Y., and Hirata, Y. (2010). 1-[5-(2-Fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl]-N methylmethanamine (TAK-438), a novel potassium-competitive acid blocker for the treatment of acid-related diseases. Journal of Pharmacology and Experimental Therapeutics, 335(1), 231–238.
21. Scott, L. J. (2018). Vonoprazan: First global approval. Drugs, 78(1), 101–107.
22. Oshima T, Miwa H. Potent Potassium-competitive Acid Blockers: A New Era for the Treatment of Acid-related Diseases. J Neurogastroenterol Motil 2018; 24:334-344. https://doi.org/10.5056/jnm18029
23. Graham, D. Y., Lee, Y. C., and Wu, M. S. (2015). Rational Helicobacter pylori therapy: Evidence-based medicine rather than medicine-based evidence. Clinical Gastroenterology and Hepatology, 13(3), 486–495.
24. Chauhan A, Mittu B, Chauhan P. Analytical method development and validation: a concise review. J Anal Bioanal Tech. 2015; 6(1): 1-5.
25. Ramole R., Baile M., Jain A. A review: Analytical method development and validation. Systematic Reviews in Pharmacy, 2021; 12(8): 450-455.
26. Puja S. Gaikwad, Dr. Vikas V. Patil, Mr. Pankaj S. Patil., Mr. Amol R. Pawar (2025). Development and validation of RP-HPLC method for estimation of Vonoprazan in bulk drug and formulation. International Journal of Innovative Research In Technology (IJIRT), 12(2), 2007-2014.
27. Kealey, D., and Haines, P. J. (2002). BIOS Instant Notes in Analytical Chemistry. Garland Science.
28. Jatto E, Okhamafe AO. An overview of pharmaceutical validation and process controls in drug development. Trop J Pharm Res 2002; 1:115-122.
29. Rao, Tentu Nageswara. ‘Validation of Analytical Methods’. Calibration and Validation of Analytical Methods - A Sampling of Current Approaches, InTech, 25 Apr. 2018. Crossref, doi:10.5772/intechopen.72087.
30. Lavanya G, Sunil M, Eswarudu MM, Eswaraiah MC, Harisudha K, Spandana BN, et al. Analytical method validation: an updated review. Int J Pharm Sci Res 2013; 4:1280.
31. Alzaghal, N. M., El-Mossalamy, E. S. H., and El-Sayed, G. O. (2024). Method Development and Validation for Estimation of Vonoprazan by RP-HPLC method in bulk and tablets dosage form. Egyptian Journal of Chemistry, 67(2), 145-159.
32. Alka N Choudharya, Tanya Sehgal, 2021. A review on pharmaceutical validation and its implications. Jour. of Med. P’ceutical and Allied. Sci. V 10 - I 6, 1927, P- 3951-3959. doi:10.22270/ jmpas. 2021.V10I6.1927.
33. MS Patil, RR Patil, SS Chalikwar, SJ Surana and SD Firke. Analytical method development and validation: A review. International Journal of Pharmaceutical and Biological Science Archive 2019; 7(3), 70-81.
34. Ashvini Pawar, Shivnath Shinde, Shrikrishna Baokar, Rajendra Patil. Analytical method validation: ICH and USP perspectives. International Journal of Research and Review. 2025; 12(8): 70-77. DOI: https://doi.org/10.52403/ijrr.20250809.
35. Patil, P. and Patil, G. and Sonawane, R. and Bagul, Vijay and Tiwari, Anand. (2025). Development and Validation of an Eco-friendly RP-HPLC Method for Vonoprazan: A QbD Approach. Chromatographia. 88. 809-826. 10.1007/s10337-025-04440-5.
36. Sharma, S., Goyal, S., and Chauhan, K. (2018). A REVIEW ON ANALYTICAL METHOD DEVELOPMENT AND VALIDATION. International Journal of Applied Pharmaceutics, 10(6), 8–15. https://doi.org/10.22159/ijap.2018v10i6.28279.
37. B.K. Sharma. 2004 “Instrumental Methods Of Chemical Analysis.”, Goel Publishing House, Meerut, 20th edition: 163-167.
38. Kazakevich, Yuri; LoBrutto, Rosario, eds. (2007). HPLC for pharmaceutical scientists. Hoboken, NJ: Wiley- Interscience. ISBN 978-0-471-68162-5.
39. Ganesh, V.; Poorna Basuri, P.; Sahini, K.; Nalini, C.N. (2023). "Retention behaviour of analytes in reversed‐phase high‐performance liquid chromatography—A review". Biomedical Chromatography. 37 (7): e5482. doi:10.1002/bmc.5482. ISSN 0269-3879. PMID 35962484. S2CID 251540223.
40. Ahamed, Mr and M. Hariharan, M. Hariharan and G.Hemamalini, G. Hemamalini and Nowfaldeen, M.Harshath and M.Hemalatha, M.Hemalatha and R.Hemnath, R.Hemnath. (2025). Analytical Method and Validation for Estimation of Vonoprazan in Pharmaceutical Dosage Form – A Review. International Journal of Pharmaceutical Research and Applications. 10. 177-185. 10.35629/4494-1005177185.
41. Thomas H. Walter, Richard W. Andrews, Richard, Recent innovations in UHPLC columns and instrumentation. Trends in Analytical Chemistry (2014), 63, 14–20. Doi: 10.1016/j.trac.2014.07.016.
42. Rathod, R. H., Chaudhari, S. R., Patil, A. S. et al. Ultra-high-performance liquid chromatography-MS/MS (UHPLC-MS/MS) in practice: analysis of drugs and pharmaceutical formulations. Future J Pharm Sci 5, 6 (2019). https://doi.org/10.1186/s43094-019-0007-8.
43. Shukla, R., Singh, P. K., and Upadhyay, S. (2023). A comprehensive review of high-performance thin layer chromatography (HPTLC). IJPPR Human, 27(1), 398-410.
44. Ravekar P. G., and Jawarkar, S. G. (2025). Analytical method development and validation for simultaneous estimation of API in pharmaceutical dosage form by using RP-HPLC method. International Journal for Research Trends and Innovation, 10(8), a600-a609 https://www.ijrti.org (ISSN: 2456-3315).