Quantification of active pharmaceutical ingredients in commercially available poly pharmaceutical tablets by means of DSC

Differential scanning calorimetry is the first line technique indispensable for industrial quality controllaboratories and, next to many routine applications, could be used in quantitative assays. For this purpose, a relationship between the signal value of analyte (enthalpy change ΔH) and its concentration in the matrix isused. However, there are several limitations of its application, concerning solid state interactions between APIs, other APIs and/or coexisting excipients. With respect to their physical properties, it is known that amorphization state and/or permanent particle deformation can produce relatively large areas of interparticle contact and thus high particle-particle bonding forces. Finally, it may affect the DSC quantitative measurements. The problem was shown using commercially available, different poly component tablets containing ibuprofen in the presence of pseudoephedrine hydrochloride or paracetamol and coexisting excipients.