Abstract

RECENT ADVANCES IN RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR PHARMACEUTICAL ANALYSIS: A REVIEW

Sakshi Sharma, *Dr. Poonam Talwan, Dr. Babita Patial, Dr. Darsh Gautam, Prof. Dr. Sanjay Kumar

Abstract

Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) is one of the most widely utilized analytical techniques in pharmaceutical research, quality control, and drug development. The technique offers excellent resolution, sensitivity, reproducibility, and versatility for the separation and quantification of pharmaceutical compounds. RP-HPLC plays a crucial role in the analysis of active pharmaceutical ingredients (APIs), impurities, degradation products, biological samples, and pharmaceutical formulations. Recent developments in stationary phase technology, column chemistry, detector systems, automation, and software-assisted method optimization have significantly improved the efficiency and reliability of RP-HPLC methods. Furthermore, the implementation of green analytical chemistry principles and advanced validation approaches has enhanced the sustainability and regulatory compliance of chromatographic methods. Method development and validation remain essential components of pharmaceutical analysis to ensure accuracy, precision, specificity, robustness, and reproducibility of analytical results. This review discusses the fundamental principles, instrumentation, method development strategies, validation requirements according to ICH guidelines, recent technological advances, and pharmaceutical applications of RP-HPLC. The article also highlights the advantages, limitations, and future prospects of RP-HPLC as an indispensable analytical tool in modern pharmaceutical sciences.

Keywords: RP-HPLC, Pharmaceutical Analysis, Method Development, Method Validation, ICH Guidelines, Quality Control, Chromatography.