ANALYTICAL QUALITYBYDESIGN DRIVEN STABILITY INDICATING HPLC METHOD FOR ESTIMATION OF VONOPRAZAN FUMARATE

Authors

  • NIKHIL PATIL Department of Quality Assurance, School of Pharmacy, Parul University, P. O. Limda, Ta. Waghodia, Vadodara, Gujarat-391760, India https://orcid.org/0009-0004-5139-529X
  • SHITAL PATEL Department of Quality Assurance, School of Pharmacy, Parul University, P. O. Limda, Ta. Waghodia, Vadodara, Gujarat-391760, India https://orcid.org/0000-0002-4657-7556
  • MINAL SALUNKHE Department of Quality Assurance, School of Pharmacy, Parul University, P. O. Limda, Ta. Waghodia, Vadodara, Gujarat-391760, India https://orcid.org/0009-0000-1181-3398
  • VIVEK SHRIVASTAVA Department of Pharmaceutics, School of Pharmacy, Parul University, P. O. Limda, Ta. Waghodia, Vadodara, Gujarat-391760, India

DOI:

https://doi.org/10.22159/ijap.2026v18i4.58535

Keywords:

Vonoprazan fumarate, AQbD, Stability-indicating method, HPLC

Abstract

Objective: The present study aimed to develop and validate a simple, efficient, and robust analytical quality by design (AQbD) driven stability-indicating high-performance liquid chromatography (HPLC) method for the quantification of vonoprazan fumarate(VPF) in its pharmaceutical dosage form.

Methods: An AQbD framework in conjunction with a Box-Behnken design was used to construct and optimize a stability-indicating HPLC technique. Retention time(RT) and tailing factor were used as response factors to evaluate method performance, whereas acetonitrile(ACN) concentration, flow rate, and column temperature were identified as essential method variables based on preliminary experiments. Forced degradation of VPF under International Council for Harmonisation (ICH) recommended stress settings verified specificity. The optimized approach was validated in accordance with ICH Q2 (R1).

Results: Using a mobile phase of acetonitrile: 0.1% glacial acetic acid (pH adjusted to 6.5), (80: 20% v/v), chromatographic separation was accomplished on a Shimadzu C18 (250 mm × 4.6 mm, 5.0 µm) column. A photodiode array (PDA) detector was used to measure the separation at 230 nm. The method's capacity to indicate stability was demonstrated through forced deterioration trials. Under circumstances of oxidative, basic, and acidic stress, VPF degraded, but it remained resistant to photolytic and thermal degradation. Precision (%RSD<2), accuracy (98.34-98.83 %), robustness (%RSD < 1.1 for column temperature and wavelength), and sensitivity with low detection and quantitation limit values were all demonstrated during method validation.

Conclusion: Implementation of AQbD driven systematic and risk-based approach into the development of a stability-indicating HPLC method for VPF enhanced method robustness, specificity and life cycle control.

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Published

2026-05-08

How to Cite

PATIL, N., PATEL, S., SALUNKHE, M., & SHRIVASTAVA, V. (2026). ANALYTICAL QUALITYBYDESIGN DRIVEN STABILITY INDICATING HPLC METHOD FOR ESTIMATION OF VONOPRAZAN FUMARATE. International Journal of Applied Pharmaceutics, 18(4). https://doi.org/10.22159/ijap.2026v18i4.58535

Issue

Articles In Press [Jul-Aug 2026]

Section

Original Article(s)

Copyright (c) 2026 NIKHIL PATIL, SHITAL PATEL, MINAL SALUNKHE, VIVEK SHRIVASTAVA

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.