Quantitative determination of polymorphic forms in a formulation matrix using the near infra-red reflectance analysis technique.
An analytical method based upon near infra-red reflectance measurements on solid samples is described for the determination of the polymorphic transformation of an active ingredient in a solid dosage form matrix. Calculations were performed using multiple linear regression techniques. The method was applied to mixtures of two polymorphic forms of a new chemical entity in a formulation matrix and gave recoveries close to the expected values with an acceptable reproducibility.
Gimet
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Searle Recherche et Développement, Parc de Sophia Antipolis, 06561 Valbonne Cedex, France.
Luong
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