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.