PATENT-INTEGRATED REVIEW ON BIOANALYTICAL METHODS FOR RECENT ANTIVIRAL AND ANTIBACTERIAL DRUGS

This review article delivers an in-depth examination of the bioanalytical methodologies and associated patented innovations for antiviral and antibacterial drugs from 2015 to 2025. The rapid global spread of infectious diseases, including COVID-19 and drug-resistant bacterial infections, has necessitated accelerated pharmaceutical advancements supported by robust analytical frameworks. The paper focuses on the critical role of HPLC and LC-MS/MS in drug quantification, pharmacokinetic profiling, and method validation aligned with regulatory guidelines such as ICH M10, FDA, and EMA. Incorporating over 75 references and numerous patents, the article highlights patented innovations in liposomal formulations, nanoparticle delivery systems, pediatric and mucosal dosage forms, and stability-enhanced oral/sublingual variants for drugs like Favipiravir, Remdesivir, Linezolid, Vancomycin, and Molnupiravir. Analytical strategies for matrix effect mitigation, microsampling techniques, AI-driven workflows, and challenges in harmonizing global validation standards are critically assessed. Future directions emphasize digital integration, pediatric drug development, and open-access repositories for analytical protocols and patent databases. This comprehensive perspective serves as a valuable resource for pharmaceutical scientists, regulatory authorities, and industry innovators in developing effective and regulatory-compliant therapeutic solutions. This comprehensive review provides an integrated evaluation of recent patents and analytical strategies in the development and validation of bioanalytical methods for antiviral and antibacterial drugs. Emphasis is placed on LC-MS/MS and HPLC methodologies that meet regulatory standards. An extensive survey of recent patents (2015–2025) supports the evolving landscape of drug delivery innovations and analytical challenges. This work aims to guide future pharmaceutical analysis with a focus on research gaps, matrix effects, and regulatory harmonization under ICH M10.