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

  • Pharmaceutical & Organic Compounds
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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.

Zusammenfassung

Es wurde eine DSC-Untersuchung der Zusammensetzung von 3 binären Modellsystemen pharmazeutischer Bedeutung durchgeführt. Gemische bekannter Zusammensetzung für jedes der folgenden Systeme wurden gefertigt und mittels DSC analysiert: 3,5-Dinitrobenzoesäure/Benzoesäure, Paracetamol/4-Aminobenzoesäure und Acetylsalicylsäure/Salicylsäure. Die durch Anwendung der van't Hoffschen Gleichung erhaltenen entsprechenden Zusammensetzungen wurden mit den entsprechenden theoretischen Werten und den anhand der relevanten DSC-Kurven ermittelten Schmelztemperaturen und Schmelzenthalpien verglichen.

Für jedes dieser Systeme wurde eine lineare Korrelation zwischen theoretischer Zusammensetzung, Schmelztemperatur und Schmelzenthalpie gefunden und es ergab sich, daß die DSC-Untersuchung der Zusammensetzung zur Bestimmung der Reinheit im Bereich 90–95 mol% angewendet werden kann. Dieser Bereich ist besonders in Stabilitätstests von pharmazeutischen Wirkstoffen von Interesse und hat eine reelle Bedeutung bei der Reinheitsprüfung von kommerziellen pharmazeutischen Herstellungen.

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Authors and Affiliations

  1. Department of Pharmacy, National University of Singapore, Kent Ridge, 0511, Singapore

    G. Becket & S. B. Quah

  2. Department of Chemistry, National University of Singapore, Kent Ridge, 0511, Singapore

    J. O. Hill

Authors
  1. G. Becket
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  2. S. B. Quah
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  3. J. O. Hill
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Becket, G., Quah, S.B. & Hill, J.O. A DSC compositional analysis of some binary organic mixtures of pharmaceutical significance. Journal of Thermal Analysis 40, 537–542 (1993). https://doi.org/10.1007/BF02546623

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