Analytical methods for the determination of baloxavir marboxil in different matrices: A comprehensive review

Baloxavir marboxil (BXM) is a novel antiviral agent approved for the treatment of influenza A and B. As the prodrug of baloxavir acid, it acts as an oral small-molecule inhibitor of cap-dependent endonuclease, a crucial enzyme in the initiation of influenza virus mRNA production.BXM demonstrated effectiveness in treating moderate COVID-19, rapidly decreasing influenza viral load, and decreasing the frequency of influenza-related complications. Owing to its growing clinical significance, numerous analytical methods have been developed for its determination in pharmaceutical forms and biological matrices. This review critically examines the reported analytical methods used to determine BXM, including spectroscopic, chromatographic, as well as hyphenated procedures, such as LC-MS/MS and UPLC -MS/MS. Method development procedures, validation factors, and analytical problems are all explored critically. The cost-effective and environmentally friendly approaches, as well as the accuracy, sensitivity, and applicability for routine quality control are all highlighted. The review aims to support analysts and researchers working on BXM analysis.