Development and Validation of a Derivative Spectrophotometric Method for the Estimation of Imeglimin in Bulk and Pharmaceutical Dosage Form

Objective: To develop a novel, simple and economical derivative spectrophotometric method as the literature survey indicated that no method had been reported till date for the estimation of Imeglimin a new tetrahydrotriazine-containing class of oral antidiabetic agents, the "glimins" and also there is a need for a validated UV spectrophotometric method to estimate the drug in bulk and pharmaceutical dosage forms.Materials and Methods: A UV spectrophotometric method was developed on Shimadzu UV-1800 double beam spectrophotometer using water as solvent for all measurements.The maximum absorption of Imeglimin was found to be at 237 nm for zero order and the absorbance's at its first and second derivatives were measured at 236 nm and 240 nm, respectively.Results: The developed derivative method proved to be linear in the concentration range of 2-12 μg/ml for Imeglimin and shows a good correlation coefficient.The precision of the developed method was less than the maximum permissible limit (% RSD < 2) set by the ICH guidelines.The limit of detection (LOD) and limit of quantification (LOQ) were 0.306 µg/ml and 0.9299 µg/ml, respectively.Excellent % recovery (98% -101%) with less than 2% RSD indicates that the method was accurate, also found to be robust and rugged for the intended use.Conclusion:The developed UV method was simple, eco-friendly, precise and accurate as per ICH guidelines.