"Impurity profiling" van testosteron-undecanoaat met behulp van vloeistofchromatografie-fourier transform infraroodspectrometrie

Abstract

Reversed-phase liquid chromatography (RP-LC) has been coupled to Fourier transform infrared spectrometry (FTIR) by means of a spray jet interface. The usefulness of the interface for impurity profiling of steriods has been demonstrated by the analysis of two samples of testosterone undecanoate. Valuable structural information on impurities >=5% was obtained either by library searching of the produced FTIR spectra, or by interpretation. Identification of two of the impurities, testosterone enanthate and testosterone decanoate, was hampered by the fact that both compounds may occur in a crystalline and in an amorphous state. The spectra of the compounds recorded in the amorphous state appeared to be highly similar.