Abstract

IDENTIFICATION, ISOLATION, SYNTHESIS AND CHARACTERIZATION OF ISOPROPYL ESTER IMPURITY OF GLIBENLAMIDE

Lawanya Lata Pandey* and Swagata Sarkar

ABSTRACT

The aim of this work is the detection, identification and elucidation of structure of organic impurity which may present in bulk drugs and pharmaceutical formulations. The control of impurities is currently a critical issue to the healthcare manufacturing. Various Regulatory authorities like ICH, USFDA, UK- MHRA and CDSCO are emphasizing on the requirements and the identification of impurities Active Pharmaceutical Ingredients’s (API’s) as well as finished products. International Conference of Harmonisation (ICH) formulated guidelines concerning the control and limit of impurities. In this article we have synthesized isopropyl impurity of Glibenclamide drug, which is a process related impurity. We have developed a novel method of synthesis of Isopropyl ester impurity of glibenclamide drug.

Keywords: ICH, USFDA, UK- MHRA and CDSCO.