A COMPREHENSIVE REVIEW ON ANALYTICAL METHOD DEVELOPMENT USING RP-HPLC AND RECENT ADVANCES IN PHARMACEUTICAL APPLICATIONS

Bhavesh Mali*, Kamal Singh Rathore

ABSTRACT

Reversed-phase high-performance liquid chromatography (RP-HPLC) is one of the most widely utilized analytical techniques in pharmaceutical analysis due to its high sensitivity, reproducibility, and versatility. The present review comprehensively discusses the fundamental principles of RP-HPLC, systematic strategies for analytical method development, and validation requirements in accordance with regulatory guidelines. Emphasis is placed on structured approaches such as Analytical Quality by Design (AQbD) and Design of Experiments (DoE), which enhance method robustness and lifecycle management. The review further highlights the critical role of RP-HPLC in pharmaceutical quality control, including assay determination, impurity profiling, stability-indicating studies, dissolution testing, and bioanalytical applications. Recent advancements in detector technologies, including photodiode array, fluorescence, and mass spectrometric detection, have significantly improved method sensitivity and selectivity, enabling trace-level analysis and complex matrix evaluation. Emerging trends such as green chromatography, hybrid analytical platforms, and artificial intelligence-assisted method optimization are shaping the future of chromatographic science. Despite certain challenges related to solvent consumption and method transferability, RP-HPLC continues to remain an indispensable tool in ensuring drug safety, efficacy, and regulatory compliance across the pharmaceutical lifecycle.

Keywords: RP-HPLC, Analytical Method Development, Pharmaceutical Quality Control, Method Validation, Detector Technologies.