Advances in Chromatographic Techniques for Drug Purity Determination

Abstract

Abstract: Chromatographic techniques have evolved into indispensable tools for the qualitative and quantitative determination of drug purity. The development of advanced chromatographic systems such as Ultra-Performance Liquid Chromatography (UPLC), High-Performance Thin-Layer Chromatography (HPTLC), and Gas Chromatography-Mass Spectrometry (GC-MS) has revolutionized the field of pharmaceutical analysis. These methods enable the separation, identification, and quantification of impurities and degradation products with superior resolution and sensitivity. The present study explores the fundamental principles, recent technological advancements, and comparative analysis of chromatographic techniques employed for drug purity assessment. Furthermore, it highlights the regulatory perspectives for impurity profiling, method validation according to ICH guidelines, and quality assurance practices in pharmaceutical industries. The paper concludes by emphasizing the significance of automation, hyphenated systems, and miniaturized chromatographic platforms in achieving rapid, reliable, and eco friendly analytical outcomes.

Keywords: Chromatography, Drug Purity, HPTLC, UPLC, Impurity Profiling