A DSC compositional analysis of some binary organic mixtures of pharmaceutical significance

Abstract

A DSC compositional analysis of 3 model binary systems of pharmaceutical significance has been conducted. Mixtures of known selected composition for each of the systems 3,5-dinitrobenzoic acid/benzoic acid, paracetamol/4-aminobenzoic acid and acetylsalicylic/salicylic acid were prepared and analyzed by DSC. The respective compositions derived from applications of the van't Hoff equation were correlated with the corresponding theoretical values and with the corresponding fusion temperatures and fusion enthalpies, obtained from the relevant DSC profiles. Linear correlations were found to exist between the theoretical compositions, fusion temperatures and fusion enthalpies for each of these systems and it is apparent that with suitable calibration procedures, the DSC compositional analysis method can be applied to determine the purity at the 90-95 mole% level. This level is of considerable interest in drug stability studies and has real significance in purity assays of commercial pharmaceutical preparations. © 1993 Wiley Heyden Ltd, Chichester and Akadémiai Kiadó.