USING PREPARATIVE CHROMATOGRAPHY AND NMR/LCMS/FT-IR, ISOLATION, IDENTIFICATION, AND CHARACTERIZATION OF POSACONAZOLE OXIDATIVE DEGRADATION IMPURITIES

Posaconazole is a pharmacological ingredient that is used to treat fungal infections. It comes in the form of delayedrelease tablets. During the forced degradation studies of Tablets, two unknown oxidative degradation impurities were discovered. The impurities were made from Posaconazole using meta-Chloroperoxybenzoic acid as an oxidant in the degradation process. Preparative chromatography was used to separate impurities, and spectroscopic techniques such as IR, NMR, and MS were used to deduce the structures. For the measurement of the total of six associated impurities of Posaconazole in Delayed-Release Tablets, a reverse phase HPLC technique was developed and validated according to ICH Q2 criteria