Analytical and Bioanalytical Chemistry

, Volume 408, Issue 17, pp 4547–4566 | Cite as

Determination of elemental impurities in pharmaceutical products and related matrices by ICP-based methods: a review

  • Juliano S. Barin
  • Paola A. Mello
  • Marcia F. Mesko
  • Fabio A. Duarte
  • Erico M. M. Flores
Review
Part of the following topical collections:
  1. ABC Highlights: authored by Rising Stars and Top Experts

Abstract

Interest in the determination of elemental impurities in pharmaceuticals has increased in recent years because of changes in regulatory requirements and the need for changing or updating the current limit tests recommended in pharmacopeias. Inductively coupled plasma (ICP) optical emission spectrometry and ICP mass spectrometry are suitable alternatives to perform multielemental analysis for this purpose. The main advantages and limitations of these techniques are described, covering the applications reported in the literature in the last 10 years mainly for active pharmaceutical ingredients, raw materials, and pharmaceutical dosage forms. Strategies used for sample preparation, including dissolution in aqueous or organic solvents, extraction, wet digestion and combustion methods are described, as well as direct solid analysis and ICP-based systems applied for speciation analysis. Interferences observed during the analysis of pharmaceutical products using ICP-based methods are discussed. Methods currently recommended by pharmacopeias for elemental impurities are also covered, showing that the use of ICP-based methods could be considered as a trend in the determination of these impurities in pharmaceuticals. However, the development of a general method that is accurate for all elemental impurities and the establishment of an official method are still challenges. In this regard, the main drawbacks and suitable alternatives are discussed.

Keywords

Determination of elemental impurities Pharmacopoeia Atomic spectrometry Sample preparation Heavy metals Pharmaceutical analysis 

Notes

Acknowledgments

The authors are grateful to Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq) and Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul (FAPERGS).

Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflict of interest.

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Copyright information

© Springer-Verlag Berlin Heidelberg 2016

Authors and Affiliations

  • Juliano S. Barin
    • 1
  • Paola A. Mello
    • 2
  • Marcia F. Mesko
    • 3
  • Fabio A. Duarte
    • 2
  • Erico M. M. Flores
    • 2
  1. 1.Departamento de Tecnologia e Ciência dos AlimentosUniversidade Federal de Santa MariaSanta MariaBrazil
  2. 2.Departamento de QuímicaUniversidade Federal de Santa MariaSanta MariaBrazil
  3. 3.Centro de Ciências Químicas, Farmacêuticas e de AlimentosUniversidade Federal de PelotasPelotasBrazil

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