Analytical Method Development and Validation for Estimation of Vanoprazan in Pharmaceutical Dosage Forms Including Bioanalysis: A Comprehensive Literature Review

Vanoprazan fumarate, a potassium-competitive acid blocker (PCAB), is a novel therapeutic agent for acid-related diseases. Accurate analytical methods for its quantification in pharmaceutical dosage forms and biological matrices are essential for quality control, formulation development, and pharmacokinetic studies. This review consolidates advances in analytical method development and validation for vanoprazan using UV-visible spectroscopy, high-performance liquid chromatography (HPLC), liquid chromatography-tandem mass spectrometry (LC-MS/MS), and other bioanalytical techniques. Validation according to ICH guidelines, method parameters, sample preparation, and applications are emphasized, providing a thorough overview of modern and classical methods.