Method Development and Validation of Anti-cancer and Anti-viral Drugs by Hyphenated Techniques: A Comprehensive Review

Abstract

The development and validation of analytical methods play a pivotal role in pharmaceutical research, especially in the domain of anti-cancer and anti-viral drugs, where precision, sensitivity, and reproducibility are crucial. These therapeutic classes present unique analytical challenges due to their structural complexity, instability, and diverse pharmacokinetic profiles. Hyphenated techniques, combining separation and detection technologies, have emerged as indispensable tools for overcoming these analytical barriers. Techniques such as LC-MS/MS, GC-MS, LC-NMR, and LC-FTIR provide superior selectivity, structural elucidation, and sensitivity compared to traditional methodologies. This review explores the principles, applications, and advancements of hyphenated techniques in the method development and validation of anti-cancer and anti-viral drugs. The manuscript discusses regulatory requirements, validation parameters, bioanalytical considerations, and the comparative analysis of these drug categories. Furthermore, it highlights recent innovations, including automation, miniaturization, and green chemistry approaches, offering insights into the future of pharmaceutical analysis and its alignment with personalized medicine. By presenting case studies and critical evaluations, this review provides a detailed understanding of the current landscape and future prospects of hyphenated techniques in pharmaceutical analysis