A QbD-Guided Development and Validation of RP-HPLC Method for Quantitative Estimation of Vonoprazan Fumarate

Vaishnavi Puri, Dr. Sandhya L. Borse, Vrushali Shinde, Pratik Bansode, Pavan Shelke, Dr. Abhijeet D. Kulkarni

Page No: 134-150

DOI: 10.5281/VEREDAS.2026/V16I4/12

Using a Quality by Design (QbD) approach, a unique, straightforward, sensitive, accurate, and reliable Reverse Phase–High Performance Liquid Chromatography (RP-HPLC) method was created and validated for the measurement of Vonoprazan in bulk medication and tablet dosage forms. Central composite design (CCD) was used in the chromatographic condition optimization process to methodically assess the impact of crucial technique parameters. Using an Agilent Zorbax C18 column (250 mm × 4.6 mm, 5 µm), the chromatographic separation was carried out on an HPLC system with Chromeleon 7.3 software. The wavelength used for detection was 225 nm. The ideal chromatographic conditions included a mobile phase that was supplied at a flow rate of 1.0 mL/min and contained phosphate buffer and acetonitrile in a 60:40 (v/v) ratio. This resulted in a retention period of roughly 5.2 minutes. The developed method was validated using standard metrics criteria, such as linearity, accuracy, precision, specificity, and robustness. The method showed satisfactory linearity with a correlation coefficient (r²) of 0.9939. Vonoprazan mean recovery of 99.91% confirmed the approach's accuracy, while precision testing showed %RSD values below 2.0%, indicating strong repeatability. The overall findings showed that the suggested approach has good predictability and robustness, which makes it appropriate for routine quantitative investigation of Vonoprazan in pharmaceutical formulations and bulk.

Citations

APA: Vaishnavi Puri, Dr. Sandhya L. Borse, Vrushali Shinde, Pratik Bansode, Pavan Shelke, Dr. Abhijeet D. Kulkarni (2026). A QbD-Guided Development and Validation of RP-HPLC Method for Quantitative Estimation of Vonoprazan Fumarate. DOI: 10.5281/VEREDAS.2026/V16I4/12

AMA: Vaishnavi Puri, Dr. Sandhya L. Borse, Vrushali Shinde, Pratik Bansode, Pavan Shelke, Dr. Abhijeet D. Kulkarni. A QbD-Guided Development and Validation of RP-HPLC Method for Quantitative Estimation of Vonoprazan Fumarate. 2026. DOI: 10.5281/VEREDAS.2026/V16I4/12

Chicago: Vaishnavi Puri, Dr. Sandhya L. Borse, Vrushali Shinde, Pratik Bansode, Pavan Shelke, Dr. Abhijeet D. Kulkarni. "A QbD-Guided Development and Validation of RP-HPLC Method for Quantitative Estimation of Vonoprazan Fumarate." Published 2026. DOI: 10.5281/VEREDAS.2026/V16I4/12

IEEE: Vaishnavi Puri, Dr. Sandhya L. Borse, Vrushali Shinde, Pratik Bansode, Pavan Shelke, Dr. Abhijeet D. Kulkarni, "A QbD-Guided Development and Validation of RP-HPLC Method for Quantitative Estimation of Vonoprazan Fumarate," 2026, DOI: 10.5281/VEREDAS.2026/V16I4/12

ISNAD: Vaishnavi Puri, Dr. Sandhya L. Borse, Vrushali Shinde, Pratik Bansode, Pavan Shelke, Dr. Abhijeet D. Kulkarni. "A QbD-Guided Development and Validation of RP-HPLC Method for Quantitative Estimation of Vonoprazan Fumarate." DOI: 10.5281/VEREDAS.2026/V16I4/12

MLA: Vaishnavi Puri, Dr. Sandhya L. Borse, Vrushali Shinde, Pratik Bansode, Pavan Shelke, Dr. Abhijeet D. Kulkarni. "A QbD-Guided Development and Validation of RP-HPLC Method for Quantitative Estimation of Vonoprazan Fumarate." 2026, DOI: 10.5281/VEREDAS.2026/V16I4/12