Abstract

METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF IMEGLIMIN BY UV VISIBLE SPECTROSCOPY

Dr. C. Parthiban*, G. Renuka, K. Maheshwari, K. Rithuja, K. Manoj Kumar and K. Jaswanth

ABSTRACT

The development and validation of a UV spectroscopy method for determining Imeglimin Hydrochloride in tablet formulation. The method utilized methanol as a solvent and a detection wavelength of 242nm. It was validated following ICH guidelines and demonstrated good linearity within a concentration range of 2-10 µg/mL (r2=0.9996) The method exhibited precision with low RSD values (<2%) and sensitivity with LOD and LOQ values of 0.082 µg/mL and 0.248 µg/mL, respectively. The method also showed good recovery values, indicating the absence of interferences. It was successfully applied for the determination of Imeglimin Hydrochloride in tablets. In conclusion, the UV spectrophotometric methods developed and validated in this study were found to be accurate, precise, and sensitive. Their cost-effectiveness and minimal maintenance make them suitable for use in small-scale industries where economy and time are crucial for quality control and therapeutic efficacy assurance.

Keywords: U v spectroscopy, Imeglimin HCL, Validation, Accuracy, Precession, Linearity, Assay.