ULTRA-PERFORMANCE LIQUID CHROMATOGRAPHY (UPLC) BASED ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR PHARMACEUTICAL DOSAGE FORMS: A COMPREHENSIVE REVIEW

Pinky Soni*, Aparna Arora, Anju Goyal

ABSTRACT

Liquid chromatographic techniques remain central to pharmaceutical quality evaluation, with High-Performance Liquid Chromatography (HPLC) historically serving as the primary analytical platform. Technological refinement has led to Ultra-Performance Liquid Chromatography (UPLC), which preserves HPLC separation principles while significantly improving efficiency, resolution, and analytical speed. UPLC is increasingly adopted for assay determination, impurity profiling, and stability-indicating analysis of pharmaceutical dosage forms. Method development and validation strategies for UPLC remain grounded in regulatory frameworks originally established for HPLC but require refined optimization due to high-pressure operation and sub-2 μm particle columns. This review presents foundational HPLC concepts, the scientific evolution toward UPLC, systematic method development workflows, validation requirements, dosage form applications, comparative performance, and future directions in pharmaceutical analysis.

Keywords: Ultra-Performance Liquid Chromatography (UPLC), High-Performance Liquid Chromatography (HPLC), Analytical Method Development, Method Validation, Pharmaceutical Dosage Forms, Chromatographic Analysis, Stability-Indicating Methods.