Analytical Method Development and Validation of Vonoprozon Fumarate: A Comprehensive Review of UV-Spectroscopic, RP-HPLC, HPTLC, AND LC-MS/MS Approaches.

Author

Rajkumar. A, Alagar Raja .M, Gayathri K, Saran Raj G, Sethupathy A, Snekha M, Rajkumar.N


Abstract

 For the treatment of Helicobacter pylori, gastroesophageal reflux disease, and peptic ulcer healing; a first-in-class potassium competitive acid blocker (P-CAB) known as vonoprazan fumarate has gained much attention as an alternative to proton pump inhibitors. This review scrutinizes the twenty-eight research reports investigating UV-spectrophotometry, reversed-phase high-performance liquid chromatography (RP-HPLC), high-performance thin-layer chromatography (HPTLC), and LC-MS/MS hyphenated bioanalytical methodologies published. The rising popularity of VNP as a therapeutically effective pharmaceutical entity triggered a paradigm shift in analytical space resulting in the generation of a significant amount of methodological literature. The present review reports chromatographic conditions, wavelength, range, linearity, limit of detection and quantification, precision, and recovery data for individual and combined dosage forms of vonoprazan along with amoxicillin, clarithromycin, domperidone, levosulpiride, and aspirin. Analytical Quality-by-Design, stability indicating, and green chemistry assessment approaches were considered independently for each methodology and critically evaluated in a master comparison table for quick access and easy understanding. The review highlights the research gaps like the absence of HPTLC and green-sustainable methodologies and provides an insight into future possibilities for the development of eco-friendly RP-HPLC and stability indicating assay procedures by applying the Quality-by-Design approach suitable for the routine analysis of vonoprazan fumarate formulations. The review further underlines the lack of dissolution, impurity profiling data, and forced degradation studies reported.



Keywords

Vonoprazan fumarate; potassium-competitive acid blocker; RP-HPLC; HPTLC; UV spectrophotometry; LC-MS/MS; bioanalytical validation; stability-indicating method; Analytical Quality by Design; green analytical chemistry



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References


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