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Evaluation of thermal stability of enalapril maleate tablets using thermogravimetry and differential scanning calorimetry

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Abstract

Differential scanning calorimetry (DSC) and thermogravimetry (TG) were used in order to evaluate the thermal stability of an enalapril maleate formulation packaged in two types of packaging, polyvinyl chloride/aluminum blister and aluminum strip. Enalapril and the excipients employed in the formulation were also evaluated by TG and DSC. Tablets were analyzed before and after storage in an acclimatized room at 40 °C and relative humidity of 75 % for 90 days. The DSC and TG results were compared with the results of dosage of enalapril and related compounds obtained by high-performance liquid chromatography. These results indicate an occurrence of chemical interaction between enalapril maleate and the excipients during its storage. After storage, it was observed that the enalapril content reduced and the predominant degradation product was diketopiperazine for both types of packaging. The predominance of diketopiperazine could be related to the absence of sodium bicarbonate in the tablets, alkalinizing agent employed in the thermal stabilization of the drug.

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Authors and Affiliations

  1. Faculdade de Farmácia, Universidade Federal de Goiás – UFG, Rua 240, esquina com 5ª Avenida, s/n, Setor Leste Universitário, Goiânia, Goiás, CEP: 74605-170, Brazil

    Steffany Manzan Marques de Souza & Edemilson Cardoso da Conceição

  2. LAMES – Laboratório de Métodos de Extração e Separação, Instituto de Química, Universidade Federal de Goiás – UFG, Campus Samambaia, Goiânia, Goiás, CEP: 74001-970, Brazil

    Pedro Ivo Brandão e Melo Franco & Maria Inês Gonçalves Leles

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  1. Steffany Manzan Marques de Souza
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  2. Pedro Ivo Brandão e Melo Franco
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  3. Maria Inês Gonçalves Leles
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  4. Edemilson Cardoso da Conceição
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Correspondence to Steffany Manzan Marques de Souza.

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de Souza, S.M.M., e Melo Franco, P.I.B., Leles, M.I.G. et al. Evaluation of thermal stability of enalapril maleate tablets using thermogravimetry and differential scanning calorimetry. J Therm Anal Calorim 123, 1943–1949 (2016). https://doi.org/10.1007/s10973-015-4648-3

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  • DOI: https://doi.org/10.1007/s10973-015-4648-3

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