Stability indicating green HPLC method for Imeglimin hydrochloride determination in pharmaceutical tablets with comprehensive assessment

Abstract In this study, an ion pair RP-HPLC method has been developed for separation and quantification of imeglimin hydrochloride (IMG) in the existence of its processing impurity, metformin hydrochloride (MTF). The chromatographic analysis was performed using an XTerra ® RP8 column (5 μm, 150 × 4.6 mm) with a mobile phase consisting of a filtered and degassed mixture of 0.1% 1-octane sulfonic acid sodium salt and absolute ethanol (80:20, %v/v ) at a constant flow rate of 1 mL/min. Detection was performed at 241 nm using a photo diode array (PDA) detector. The method parameters were thoroughly evaluated and validated in accordance with ICH Q2 (R2) guidelines. Linearity was established over the range of 0.4–96.0 µg. mL − 1 . The use of ion pairing with octane sulfonic acid and ethanol as the mobile phase was effective in achieving an acceptable retention time for the determination of IMG in the presence of metformin and IMG degradation products. Peak purity analysis using PDA detector confirmed that degradation products did not interfere with IMG detection. Furthermore, the method was successfully applied for the accurate quantification of IMG in tablet dosage form, with no interference from excipients, confirming its specificity. Additionally, it was effectively utilized for in vitro dissolution testing of IMG in tablet form, following FDA guidelines. The greenness and applicability of the developed method were assessed using various tools such as the Analytical Eco-Scale, AGREE, MOGAPI, CAFRI, CACI and BAGI demonstrating its environment friendly nature and practicality.