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

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.