RP-HPLC Method for Determination of Imeglimin Hydrochloride in Bulk and Tablet Formulation

Abstract

Imeglimin hydrochloride (IMEG.HCl) is a new tetrahydro triazine-containing class of oral antidiabeticagents referred to as ‘glimins’, is used to treat type 2 diabetes (T2D). It is the firstanti-diabetic drug of this type to receive approval. It is an inhibitor of oxidative phosphorrylation that also works to improve muscle glucose absorption and restore regular insulin secretion¹. A reverse phase HPLC method was developed and validated for quantitative determination of Imeglininhydrochlorideusing a BRISA LC² C18 (25 mm x 0.46 mm, 5µm) Column, isocratic mobile phase of Methanol: Phosphate buffer (10mM) pH6.0, at a flow rate of 1ml/min. The analyte was monitored at 243nm and retention time was found to be 3.097min.The peak obtained was symmetrical with tailing factor less than 2 and theoretical plates more than 2000. The developed HPLC method showed good linearity (R²=1), the intra- and inter-day precision was less than 2%, LOD and LOQ were 0.137 and 1.417 μg/ml andaccuracy for three different levels was found to be 101.23%w/w-100.83%w/w respectively.The method was validated in accordance with ICH guidelines Q2 (R1).² and was found to be Specific, Accurate, Precise, Robust and can be successfully applied for routine analysis of Imeglininhydrochloridein bulk and in pharmaceutical dosage form.