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Counterfeit drugs: analytical techniques for their identification

Abstract

In recent years, the number of counterfeit drugs has increased dramatically, including not only “lifestyle” products but also vital medicines. Besides the threat to public health, the financial and reputational damage to pharmaceutical companies is substantial. The lack of robust information on the prevalence of fake drugs is an obstacle in the fight against drug counterfeiting. It is generally accepted that approximately 10% of drugs worldwide could be counterfeit, but it is also well known that this number covers very different situations depending on the country, the places where the drugs are purchased, and the definition of what constitutes a counterfeit drug. The chemical analysis of drugs suspected to be fake is a crucial step as counterfeiters are becoming increasingly sophisticated, rendering visual inspection insufficient to distinguish the genuine products from the counterfeit ones. This article critically reviews the recent analytical methods employed to control the quality of drug formulations, using as an example artemisinin derivatives, medicines particularly targeted by counterfeiters. Indeed, a broad panel of techniques have been reported for their analysis, ranging from simple and cheap in-field ones (colorimetry and thin-layer chromatography) to more advanced laboratory methods (mass spectrometry, nuclear magnetic resonance, and vibrational spectroscopies) through chromatographic methods, which remain the most widely used. The conclusion section of the article highlights the questions to be posed before selecting the most appropriate analytical approach.

DOSY spectrum of a counterfeit artesunate tablet containing paracetamol instead of artesunate

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Correspondence to M. Malet-Martino.

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Martino, R., Malet-Martino, M., Gilard, V. et al. Counterfeit drugs: analytical techniques for their identification. Anal Bioanal Chem 398, 77–92 (2010). https://doi.org/10.1007/s00216-010-3748-y

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Keywords

  • Counterfeit drugs
  • Colorimetry
  • Chromatography
  • Mass spectrometry
  • Diffusion-ordered 1H NMR spectroscopy
  • Vibrational spectroscopies