A Novel Method Development and Validation of Imeglimin HCl By UV Visible Spectroscopy

Tamil Selvan R , Senthilkumar S K , HARI PRAKASH G, Elakkiya A., Gayatri M., Gokulraj M., Hajima H.,

doi:10.5281/zenodo.10433883

Research Paper | Open Access
Volume 01 | Issue 12 | Article Id IJPS/230112128

A Novel Method Development and Validation of Imeglimin HCl By UV Visible Spectroscopy
Tamil Selvan R * Senthilkumar S K HARI PRAKASH G Elakkiya A. Gayatri M. Gokulraj M. Hajima H.
^*1Associate Professor, Department of Pharmaceutical Analysis, Arunai College of Pharmacy, Tiruvannamalai, Tamil Nadu 606603
²Principal cum Professor, Arunai College of Pharmacy, Tiruvannamalai, Tamil Nadu 606603
³students, Arunai College of Pharmacy, Tiruvannamalai, Tamil Nadu 606603

Abstract

The development and validation of a UV spectroscopy method for determining Imeglimin Hydrochloride in tablet formulation. The method utilized distilled water as a solvent and a detection wavelength of 237 nm. It was validated following ICH guidelines and demonstrated good linearity within a concentration range of 2-10 µg/mL (r2=0.9991). The method exhibited precision with low RSD values (<2%) and sensitivity with LOD and LOQ values of 16.74 µg/mL and 50.73 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

Imeglimin Hydrochloride, antidiabetic, type 2, UV-Vis spectroscopy.

Reference

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Tamil Selvan R

Corresponding author

Associate Professor, Department of Pharmaceutical Analysis, Arunai College of Pharmacy, Tiruvannamalai,Tamil Nadu 606603

Senthilkumar S K

Co-author

Principal cum Professor, Arunai College of Pharmacy, Tiruvannamalai, Tamil Nadu 606603