A NOVEL ROUTE FOR THE SYNTHESIS OF IMPURITIES G OF ANTIDIABETIC DRUG GLICLAZIDE
Nand Lal Mali*, Prof. Rajeev Mehta, Prof. Preeti Mehta, Dr. Pankaj Sen
ABSTRACT
The study reports the synthesis and characterization of Gliclazide Impurity G, developed for the first time with high yield and excellent purity. The synthetic strategy was optimized to ensure efficiency and reproducibility, providing a reliable pathway for laboratory and potential industrial applications. Purity assessment of the synthesized impurity was carried out using High-Performance Liquid Chromatography (HPLC), which confirmed its high chemical integrity and suitability for analytical studies. Structural elucidation was further performed by employing proton nuclear magnetic resonance (1H NMR) spectroscopy and mass spectrometry, both of which provided detailed confirmation of the molecular framework and functional groups. These combined techniques validated the identity of the impurity with high precision. The successful preparation and complete characterization of Gliclazide Impurity G hold significant value for pharmaceutical quality control, regulatory submissions, and future research aimed at understanding drug metabolism, degradation pathways, and ensuring safety in therapeutic formulations.
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