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

Vitoria Hagemann Cauduro, Alessandra Schneider Henn, Rochele Sogari Picoloto, Edson Irineu Muller, Marcia Foster Mesko and Erico Marlon Moraes Flores
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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

Sustainability, 2021, vol. 14, issue 1, 1-16

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).

Keywords: elemental impurities; MAWD; MAWD-UV; pharmaceutical products; type 2 diabetes; sample preparation; ICP-OES (search for similar items in EconPapers)
JEL-codes: O13 Q Q0 Q2 Q3 Q5 Q56 (search for similar items in EconPapers)
Date: 2021
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Persistent link: https://EconPapers.repec.org/RePEc:gam:jsusta:v:14:y:2021:i:1:p:422-:d:715480

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