A Comprehensive Review of Analytical Method Development and Validation for Imeglimin Hydrochloride.

Abstract

Imeglimin Hydrochloride is a novel oral antidiabetic agent used in the management of type 2 diabetes mellitus, characterized by its unique mechanism of action targeting mitochondrial bioenergetics. The increasing therapeutic significance of Imeglimin necessitates the development of robust, accurate, and reliable analytical methods for its identification, quantification, and quality control in bulk and pharmaceutical dosage forms. This comprehensive review focuses on the various analytical techniques developed for the estimation of Imeglimin Hydrochloride, including spectroscopic methods such as UV–Visible spectrophotometry and advanced chromatographic techniques like High-Performance Liquid Chromatography (HPLC), High Performance Thin Layer Chromatography (HPTLC), and Liquid Chromatography–Mass Spectrometry (LC– MS). Emphasis is placed on method development strategies, including selection of solvents, mobile phase optimization, detection wavelength, and column characteristics to achieve optimal sensitivity and specificity.