Green Assessment-Based Stability-Indicating Rp-Hplc Method Development And Validation For The Determination Of Vonoprazan Fumarate In Bulk And Formulations
Keywords:
RP-HPLC, Vonoprazan Fumarate, Stability-indicating assay, Validation, Forced Degradation, Greenness evaluation.
Abstract
A rapid and reliable Green Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the estimation of Vonoprazan Fumarate in pharmaceutical formulations. The method utilized a BDS Hypersil C18 column (250 × 4.6 mm, 5 µm) with a mobile phase of water (pH 3.0) and acetonitrile (95:5, v/v) under isocratic conditions. Detection was performed at 213 nm using a PDA detector, with a flow rate of 0.8 mL/min and a retention time of 3.9 minutes. Linearity was established in the 10–60 µg/mL range, with a recovery of 98.90%. The method demonstrated stability-indicating properties through forced degradation studies. Greenness was assessed using AGREE (0.86), AGREEprep (0.77), and BAGI (75), confirming its environmental and industrial feasibility. The developed RP-HPLC method, validated according to ICH guidelines, is suitable for analyzing Vonoprazan Fumarate in pharmaceutical formulations. Forced degradation studies confirmed its stability-indicating capability. This study highlights the method’s balance between efficiency and environmental responsibility.
References
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3) Liu, L., Cao, N., Ma, X., Xiong, K., Sun, L., & Zou, Q. (2016). Identification, characterization, and high‐performance liquid chromatography quantification of process‐related impurities in vonoprazan fumarate. Journal of Separation Science, 39(7), 1232-1241. https://doi.org/10.1002/jssc.201501154
4) Mahgoub, H., Ragab, M. A., Tarek, S., & Maher, H. M. (2024). An eco-friendly liquid chromatographic analysis of the triple therapy protocol of amoxicillin, metronidazole, and vonoprazan for H. pylori eradication: Application to combined dosage forms and simulated gastric fluid. BMC Chemistry, 18(1), 106.
5) Lin, B., Kou, J., Xiao, Q., Wu, S., Li, J., Zhu, Z., Zhou, X., Xin, L., Li, Y., & Wang, Z. (2022). Identification, characterization, synthesis of major metabolites bio transformed from vonoprazan fumarate. Tetrahedron, 108, 132669. https://doi.org/10.1016/j.tet.2022.132669
6) Alzaghal, N. M., El-Mossalamy, E. S., & El-Sayed, G. O. (2024). Method development and validation for estimation of vonoprazan by RP-HPLC method in bulk and tablet dosage form. Egyptian Journal of Chemistry, 67(2), 145-159. https://doi.org/10.21608/ejchem.2023.193129.7593
7) Yoneyama, T., Teshima, K., Jinno, F., Kondo, T., & Asahi, S. (2016). A validated simultaneous quantification method for vonoprazan (TAK-438F) and its 4 metabolites in human plasma by the liquid chromatography-tandem mass spectrometry. Journal of Chromatography B, 1015, 42-49. https://doi.org/10.1016/j.jchromb.2016.01.051
8) European Medicines Agency (EMA). (2018). ICH Q1A (R2) Stability Testing of New Drug Substances and Products - Scientific Guideline. Retrieved from www.ema.europa.eu
9) International Council for Harmonisation (ICH). (2023). ICH harmonised guideline validation of analytical procedures Q2(R2). Retrieved from www.ich.org
10) Mahgoub, S. M., Mahmoud, M. R., Binsaleh, A. Y., Almalki, M. A., Mohamed, M. A., & Nassar, H. F. (2023). Analytical assessment of a novel RP-HPLC method for the concurrent quantification of selected pharmaceutical drugs levodopa and carbidopa using eight greenness metrics comparing to the lean six sigma approach. Sustainable Chemistry and Pharmacy, 36, 101291. https://doi.org/10.1016/j.scp.2023.101291
11) Pena-Pereira, F., Wojnowski, W., & Tobiszewski, M. (2020). AGREE—Analytical GREEnness Metric Approach and Software. Analytical Chemistry, 92(14), 10076–10082. https://doi.org/10.1021/acs.analchem.0c01887
12) Manousi, N., Wojnowski, W., Płotka-Wasylka, J., & Samanidou, V. (2023). Blue Applicability Grade Index (BAGI) and software: A new tool for the evaluation of method practicality. Green Chemistry, 25(19), 7598–7604. https://doi.org/10.1039/d3gc02347h
13) Wojnowski, W., Tobiszewski, M., Pena-Pereira, F., & Psillakis, E. (2022). AGREEprep – Analytical greenness metric for sample preparation. Trends in Analytical Chemistry, 149, 116553. https://doi.org/10.1016/j.trac.2022.116553
Published
2024-12-28
How to Cite
Gauri N. Rajage, Vaishali B. Jadhav, Dr. Ashish Jain, Dr. Reshma V. Jadhav, Saiesh Jogdandkar, Preeti B. Ghule, Manasi S. Mahadik, & 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
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Articles
