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 eth

SUBMITTER: Mansour FR 

PROVIDER: S-EPMC12796370 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature