An Overview of Advances in the Chromatography of Drugs Impurity Profiling

Abstract

A systematic literature survey published in several journals of pharmaceutical chemistry and of chromatography used to analyze impurities for most of the drugs that have been reviewed. This article covers the period from 2016 to 2020, in which almost of chromatographic techniques have been used for drug impurity analysis. These chromatography techniques are important in the analysis and description of drug impurities. Moreover, some recent developments in forced impurity profiling have been discussed, such as buffer solutions, mobile phase, columns, elution modes, and detectors are highlighted in drugs used for the study. This primarily focuses on thorough updating of different analytical methods which include hyphenated techniques for detecting and quantifying impurity and degradation levels in various pharmaceutical matrices.

Keywords: Degradation; ICH Q3; drug substance; impurity profiling; separation of impurities.