ABSTRACT

The primary aim of this study is to develop and verify a simple, reliable, precise, and convenient UV-visible spectroscopic method for determining the quantity of Imeglimin hydrochloride, following the recommendations outlined in ICH Q2 (R1). The multivariate calibration uses linear regression analysis to establish the association between absorbance and concentration at five specific wavelengths that are evenly distributed. Using water as the solvent, Imeglimin hydrochloride displayed ????max at 240 nm. A linear plot was obtained with a regression coefficient of 0.999 for the concentrations between 5-15 ?g mL-1. The % RSD for intra-day and inter-day precision were found to be 0.197 and 0.151, respectively. The assay was determined and found to be 100.11 % w/w. Keywords: Imeglimin hydrochloride, UV-visible spectrophotometry, Multivariate calibration, ICH guidelines
Publication date: 01/03/2025

https://ijbpas.com/pdf/2025/March/MS_IJBPAS_2025_8772.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.3.8772