Influence of sample characteristics on quantification of carbamazepine hydrate formation by X-ray powder diffraction and Raman spectroscopy

This study aimed to assess the suitability of two widely utilized solid state characterization techniques namely powder X-ray diffraction (XRPD) and Raman spectroscopy, in polymorph detection and quantification for carbamazepine anhydrate and dihydrate mixtures. The influences of particle size, part...

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Bibliographic Details
Published in:European journal of pharmaceutics and biopharmaceutics 2007-06, Vol.66 (3), p.466-474
Main Authors: Tian, F., Zhang, F., Sandler, N., Gordon, K.C., McGoverin, C.M., Strachan, C.J., Saville, D.J., Rades, T.
Format: Article
Language:English
Subjects:
Biological and medical sciences
Calibration
Carbamazepine
Carbamazepine - chemistry
Carbamazepine dihydrate
Chemistry, Pharmaceutical
General pharmacology
Medical sciences
Particle Size
Pharmaceutical technology. Pharmaceutical industry
Pharmacology. Drug treatments
Powder Diffraction
Quantification
Raman spectroscopy
Spectrum Analysis, Raman
X-Ray Diffraction
X-ray powder diffraction
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Summary:This study aimed to assess the suitability of two widely utilized solid state characterization techniques namely powder X-ray diffraction (XRPD) and Raman spectroscopy, in polymorph detection and quantification for carbamazepine anhydrate and dihydrate mixtures. The influences of particle size, particle morphology, mixing, and in particular, surface bias on quantitation were investigated. Binary mixtures of carbamazepine anhydrate (form III) and dihydrate were prepared and analyzed using both XRPD and Raman spectroscopy in combination with partial least squares analysis. It was found that in principle both XRPD and Raman spectroscopy could be used to build calibration models for quantitative analysis, and a satisfactory correlation between the two techniques could be achieved. However, Raman spectroscopy appeared to be a more reliable quantification method because problems such as different particle size, morphology, and special distribution of the two solid state forms of the drug seemed to have no significant influence on Raman scattering in this study. The robust nature of Raman analysis greatly facilitates the whole quantification process from the preparation of calibration models to the quantification of in situ CBZ–DH conversion.
ISSN:0939-6411
1873-3441
DOI:10.1016/j.ejpb.2006.12.002