High-Speed Analysis of Linezolid following the Draft Guidance of International Harmonization of Pharmacopoeias

Linezolid is a new class of synthetic antibiotic with an oxazolidinone skeleton. It was approved as a therapeutic agent in the United States in 2000 and in Japan in 2001. Linezolid was also listed in the Second Supplement to the 40th Edition of the United States Pharmacopeia (USP) published in 2017. On the other hand, in international harmonization of the respective pharmacopeias, which is currently under study, the allowable range of changes in analytical conditions is specified in the draft guidance of international harmonization of JP/USP/EP. Sharing a common allowable range of changes in high speed analysis conditions by all countries is important for achieving higher efficiency in drug development.
This article introduces an example of analysis of linezolid based on the USP and an example of its high-speed analysis based on the draft guidance of international harmonization of JP/USP/EP using Shimadzu Nexera Series and Shim-pack Scepter C18. It should be noted that this draft is based on the draft version published when public comment was solicited in July 2017 and may differ from the final content.