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Quantitative analysis of mannitol polymorphs: FT-Raman spectroscopy

Campbell Roberts, S. N. C., Williams, A. C. ORCID: https://orcid.org/0000-0003-3654-7916, Grimsey, I. M. and Booth, S. W. (2002) Quantitative analysis of mannitol polymorphs: FT-Raman spectroscopy. Journal of Pharmaceutical and Biomedical Analysis, 28. pp. 1135-1147. ISSN 0731-7085

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To link to this item DOI: 10.1016/S0731-7085(02)00059-6

Abstract/Summary

Mannitol is a polymorphic excipient which is usually used in pharmaceutical products as the beta form, although other polymorphs (alpha and delta) are common contaminants. Binary mixtures containing beta and delta mannitol were prepared to quantify the concentration of the beta form using FT-Raman spectroscopy. Spectral regions characteristic of each form were selected and peak intensity ratios of beta peaks to delta peaks were calculated. Using these ratios, a correlation curve was established which was then validated by analysing further samples of known composition. The results indicate that levels down to 2% beta could be quantified using this novel, non-destructive approach. Potential errors associated with quantitative studies using FT-Raman spectroscopy were also researched. The principal source of variability arose from inhomogeneities on mixing of the samples; a significant reduction of these errors was observed by reducing and controlling the particle size range. The results show that FT-Raman spectroscopy can be used to rapidly and accurately quantitate polymorphic mixtures.

Item Type:Article
Refereed:Yes
Divisions:Life Sciences > School of Chemistry, Food and Pharmacy > School of Pharmacy > Pharmaceutics Research Group
ID Code:27365
Uncontrolled Keywords:FT-Raman spectroscopy; Mannitol; Polymorphism; Quantitation
Publisher:Elsevier

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