Development And Validation of Uv Spectrophotometry for Imeglimin Hcl Using Green Analytical Chemistry Approach

The increasing demand for novel analytical methods for recently developed drugs necessitates the development of simple, accurate, and environmentally sustainable approaches. This research was undertaken to develop and validate a UV-visible spectrophotometric method for the estimation of Imeglimin Hydrochloride, a new antidiabetic agent, using methanol as a solvent in accordance with Green Analytical Chemistry principles. The method was designed to be straightforward and cost-effective, suitable for routine quality control. Spectrophotometric analysis was conducted at 245 nm, and the method was validated following ICH guidelines, assessing parameters such as linearity, precision, accuracy, specificity, limit of detection (LOD), and limit of quantitation (LOQ). The method demonstrated excellent linearity within the concentration range of 2–10 µg/mL with a correlation coefficient close to 1. Precision and accuracy results were within acceptable limits, indicating the reliability of the method. The LOD and LOQ values confirmed the method’s sensitivity, and assay results for marketed tablet formulations verified its practical applicability. Green assessment was performed by using AGREE software and the score was 0.77 which indicates that the developed method is eco-friendly. The study successfully developed a validated, green, and robust method for the estimation of Imeglimin Hydrochloride, providing a sustainable tool for pharmaceutical analysis.