Masking derivatization was introduced for the determination of residual solvents in samples containing a volatile reactive matrix component(s). Isobutylboronic acid, used in the last step of Bortezomib synthesis, represents a compound passing to the gas phase and deteriorating a chromatographic column during a headspace analysis. The masking derivatization with 1,8-diaminonaphthalene allowed a simple and straightforward conversion of isobutylboronic acid to a stable nonvolatile derivative and thus prevented gas chromatography column deterioration. The method was successfully validated according to the guidelines of International Committee for Harmonization (Q3C (R6) Guideline for Residual Solvents) and international pharmacopoeias (Ph. Eur., USP) and approved by Teva Czech Industries for routine application.

Regional Centre of Advanced Technologies and Materials Department of Analytical Chemistry Faculty of Science Palacký University Olomouc Czech Republic

Teva Czech Industries s r o Opava Czech Republic

Citace poskytuje Crossref.org