Abstract

HARMONIZATION OF EUROPEAN PHARMACOPEIAL AND US PHARMACOPEIAL METHODS OF GLIMEPIRIDE BY HPLC

Dr. Amit Gosar and Sagar Gaikwad*

Abstract

Glimepiride is official in both EP and USP. For analysis of this product three High performance liquid chromatography methods are reported in EP as well as USP. These methods are Assay, Related substances analysis and analysis of cis impurity (by chiral HPLC). This research paper includes the harmonization of three methods with respect to EP and USP monographs. This will lead to common analysis method for both EP as well as USP, saving time and cost of analysis. The harmonized methods are validated as per International Conference on Harmonization guidelines.

Keywords: Glimepiride, Related substances, Assay, Chiral and High performance liquid chromatography, Harmonization and Cost saving.