A simple protocol for the characterization of fraudulent erectile dysfunction medicines using ion beam analytical techniques
• Protocol based on the detection of Sulphur by PIXE on erectile dysfunction medicines. • 7 brands of medicine were analyzed with RBS, PIXE and MeV-SIMS. • Sildenafil-, tadalafil-, vardenafil-based medicine and a supplement were analyzed. • Protocol suitable for discrimination of Sildenafil and vardenafil medicines. In this work we developed a simple and fast protocol based solely on ion beam analytical techniques for the analysis of erectile dysfunction medicines containing sildenafil and vardenafil as active ingredients. To that end, RBS (Rutherford Backscattering Spectrometry), PIXE (Particle-Induced X-ray Emission) and MeV-SIMS (Secondary Ion Mass Spectrometry) were employed in the analysis of sildenafil citrate (Viagra®), vardenafil hydrochloride (Levitra®) and tadalafil (Cialis®) among other medications. The RBS and PIXE techniques provide information on the concentrations of major and trace elements present in the tablets respectively, while the MeV-SIMS technique was used for the determination of the molecular profile of the samples. The protocol is based on the detection of sulfur present in the tablets through the PIXE technique, while its validation relies on the detection of the active ingredients with the MeV-SIMS technique. The results confirm that the protocol is quite suitable for the discrimination of different sildenafil- and vardenafil-based medicines. On the other hand, this protocol cannot be used for the study of tadalafil-based medicines since no detectable element by PIXE is present in its active ingredient.
Authors
- Raquel Silva Thomaz
- Rafaela Debastiani (ORCID: https://orcid.org/0000-0003-4396-8612)
- Paola Chytry
- Johnny Ferraz Dias (ORCID: https://orcid.org/0000-0002-1751-9541)
- Luı́sa M.P.F. Amaral (ORCID: https://orcid.org/0000-0002-7158-2699)
- Guilherme Maurício Soares de Souza (ORCID: https://orcid.org/0000-0001-6849-6346)
- Matteo Knebel
Institutions
- Karlsruhe Institute of Technology (DE)
- Universidade Federal do Rio Grande do Sul (BR)
- Pontifícia Universidade Católica do Rio Grande do Sul (BR)
Publication Details
- Journal
- Microchemical Journal
- Published
- 2025-04-14
- DOI
- https://doi.org/10.1016/j.microc.2025.113602
- Citations
- 2
- Primary Topic
- Pharmaceutical Quality and Counterfeiting
- Type
- article
- Field-Weighted Citation Impact
- 3.76
Funders
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul