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Development of Green Methods for the Determination of Elemental Impurities in Commercial Pharmaceutical Tablets

Author

Listed:
  • Vitoria Hagemann Cauduro

    (Departamento de Química, Universidade Federal de Santa Maria, Santa Maria 97105-900, Brazil)

  • Alessandra Schneider Henn

    (Departamento de Química, Universidade Federal de Santa Maria, Santa Maria 97105-900, Brazil)

  • Rochele Sogari Picoloto

    (Departamento de Química, Universidade Federal de Santa Maria, Santa Maria 97105-900, Brazil)

  • Edson Irineu Muller

    (Departamento de Química, Universidade Federal de Santa Maria, Santa Maria 97105-900, Brazil)

  • Marcia Foster Mesko

    (Centro de Ciências Químicas, Farmacêuticas e de Alimentos, Universidade Federal de Pelotas, Capão do Leão 96160-000, Brazil)

  • Erico Marlon Moraes Flores

    (Departamento de Química, Universidade Federal de Santa Maria, Santa Maria 97105-900, Brazil)

Abstract

In this study, two methods based on the use of diluted acids were developed: microwave-assisted wet digestion (MAWD) and microwave-assisted ultraviolet digestion (MAWD-UV). These methods are evaluated for the digestion of oral pharmaceutical drugs and further determination of elemental impurities from classes 1 (As, Cd, Hg and Pb) and 2A (Co, Ni and V) by inductively coupled plasma optical emission spectrometry (ICP-OES). Commercial drugs for the treatment of type 2 diabetes are used. No prior comminution is performed. For MAWD, the optimized conditions were 2 mol L −1 or 3 mol L −1 HNO 3 , 1 mL of 50% H 2 O 2 and a 45 min or 55 min irradiation program. For MAWD-UV, the condition using 1 mol L −1 HNO 3 , 1.6 mL of 50% H 2 O 2 and a 55 min irradiation program enabled the digestion of all samples. In this way, efficient methods are proposed for the digestion of commercial pharmaceutical tablets for further determination of class 1 and 2A elemental impurities (ICH Q3D guidelines).

Suggested Citation

  • Vitoria Hagemann Cauduro & Alessandra Schneider Henn & Rochele Sogari Picoloto & Edson Irineu Muller & Marcia Foster Mesko & Erico Marlon Moraes Flores, 2021. "Development of Green Methods for the Determination of Elemental Impurities in Commercial Pharmaceutical Tablets," Sustainability, MDPI, vol. 14(1), pages 1-16, December.
    • Handle: RePEc:gam:jsusta:v:14:y:2021:i:1:p:422-:d:715480
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