Spectroscopic evaluation on pseudopolymorphs of sodium naproxen.

This paper demonstrates the assessment of vibrational spectroscopy methods such as middle infrared, near infrared and Raman spectroscopy (FTIR, FT-NIR, Raman) for the identification of pseudopolymorphic forms of a model active pharmaceutical ingredient (API) - sodium naproxen (NpxNa). NpxNa, in the form of three different pseudopolymorphs, was investigated by methods dedicated for solid state characterization: DSC (differential scanning calorimetry), XPRD (powder X-ray diffraction), SEM (scanning electron microscopy) and Karl Fischer titration. Novelty in the results sourced in the usage of the method not applied so far to identify pseudopolymorphic forms of NpxNa, that is, FTIR and FT-NIR. Based on the obtained reproduceable results, various pseudopolymorphic forms were successfully evaluated. Spectroscopic data were correlated with DSC and XPRD results. It was concluded that the combination of band's variations visible on the spectra of pseudopolymorphic forms will allow to interpretate the results unequivocally in case of crucial stability tests of medicinal substance or during on-line pharmaceutical process development by FTIR, FT-NIR and Raman spectroscopy.

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Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.