ABSTRACT:
A stability-indicating high-performance thin-layer chromatography (HPTLC) approach was produced and validated for the quantitative determination of Vonoprazan Fumarate in bulk and tablet dosage form utilizing a Quality by Design approach. Method was optimized through systematic risk evaluation and experimental design to ensure robustness and reliability. Chromatographic separation was achieved using HPTLC plates coated by silica gel 60 F254 with mobile phase consisting of Ethyl Acetate: n-Hexane: Glacial Acetic acid (5:4:1v/v/v) by response surface methodology. The identification was done at ?max 215 nm. Developed method demonstrated linearity (r² > 0.999) over the concentration range of 200–1200 ng/spot. The LOD and LOQ were found to be 2.96 ng/spot and 8.98 ng/spot, respectively. Accuracy was demonstrated by recovery studies at three concentration levels, yielding mean recoveries between 99.05to 103.48%. Intra-day % RSD (1.08 to 1.90%) and inter day % RSD (1.09 to 1.32 %), precision studies showed %RSD values below 2%, indicating the method’s repeatability and reliability. Forced degradation studies under acidic, basic, oxidative, thermal, and photolytic conditions confirmed the stability-indicating studies of the method, as degradation products were well resolved by analyte peak. The method was validated as per International Council for Harmonization Q2(R1) guidelines for accuracy, precision, specificity, and robustness. The application of Box-Behnken Design principles ensured method robustness and reproducibility, making it suitable for regular analysis of quality control for Vonoprazan Fumarate in pharmaceutical products. This study highlights significance for systematic analytical method development in regulatory compliance and quality assurance.
Cite this article:
Pratibha L. Ayanar, Kumudini R. Pawar. A QbD-based Stability Indicating Study for the Development and Validation of Vonoprazan Fumarate by HPTLC Method. Research Journal of Pharmacy and Technology. 2026;19(7):3317-4. doi: 10.52711/0974-360X.2026.00472
Cite(Electronic):
Pratibha L. Ayanar, Kumudini R. Pawar. A QbD-based Stability Indicating Study for the Development and Validation of Vonoprazan Fumarate by HPTLC Method. Research Journal of Pharmacy and Technology. 2026;19(7):3317-4. doi: 10.52711/0974-360X.2026.00472 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2026-19-7-59
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