Fingerprinting of sildenafil citrate and tadalafil tablets in pharmaceutical formulations via X-ray fluorescence (XRF) spectrometry

Autor(es)

Ortiz, Rafael S. ^{[1, 2]} ; Mariotti, Kristiane C. ^[2] ; Schwab, Nicolas V. ^[3] ; Sabin, Guilherme P. ^[3] ; Rocha, Werickson F. C. ^[4] ; de Castro, Eustaquio V. R. ^[5] ; Limberger, Renata P. ^[2] ; Mayorga, Paulo ^[2] ; Bueno, Maria Izabel M. S. ^[3] ; Romao, Wanderson ^[5]

Afiliação do(s) autor(es)

^[1] Brazilian Fed Police, Rio Grande Sul Tech & Sci Div, BR-90160093 Porto Alegre, RS - Brazil

^[2] Univ Fed Rio Grande do Sul, Dept Pharm, BR-90610000 Porto Alegre, RS - Brazil

^[3] Univ Estadual Campinas, Inst Chem, BR-13084971 Campinas, SP - Brazil

^[4] Natl Inst Metrol Standardizat & Ind Qual, Directorate Ind & Sci Metrol, Div Chem Metrol, BR-25250020 Rio De Janeiro - Brazil

^[5] Univ Fed Espirito Santo, Dept Chem, BR-29075910 Vitoria, ES - Brazil

• Tipo de documento: Artigo Científico
• Fonte: Journal of Pharmaceutical and Biomedical Analysis; v. 58, p. 7-11, JAN 25 2012.
• Citações Web of Science: 27

Resumo

The production of counterfeited drugs is a criminal problem that carries serious risks to public health in the worldwide. In Brazil, Viagra (R) and Cialis (R) are the most counterfeit medicines, being used to inhibit the phosphodiesterase type 5 (PDE-5), treating thus, problems related to erectile dysfunction. X-ray fluorescence (XRF) is a suitable technique to control the quality of new pharmaceutical formulations and distinguish between authentic and counterfeit tablets. XRF has advantageous features like multielemental capability, good detectivity, high precision, short analysis times, and is nondestructive, which makes it suitable to be extended to a great variety of samples. In this work, the inorganic fingerprinting chemical of forty-one commercial samples (Viagra (R), Cialis (R), Lazar (R), Libiden (R), Maxfil (R), Plenovit (R), Potent 75 (R), Rigix (R), V-50 (R), Vimax (R) and Pramil (R)) and fifty-six counterfeit samples (Viagra and Cialis) were obtained from XRF data. XRF presented an excellent analytical methodology for semi-quantitative determination of active ingredient (in case of sildenafil citrate that presents S in its structure) and excipients such as calcium phosphate, titanium oxide and iron oxide (P, Ca, Ti and Fe). The matrix data were allied to chemometric methods (Principal Component Analysis and Hierarchical Cluster Analysis) to classify the tablets investigated between authentic and counterfeit, grouping the samples into of seven groups: A, B, C, D and E (counterfeit group) and F and G (authentic group). Crown Copyright (C) 2011 Published by Elsevier B.V. All rights reserved. (AU)

• Processo FAPESP: 09/07168-9 - Novas aplicações da espectrometria de massas em química forense
• Beneficiário: Wanderson Romão
• Modalidade de apoio: Bolsas no Brasil - Doutorado
• Processo FAPESP: 07/54357-6 - Caracterizacao de produtos lacteos por novas tecnicas em espectrometria de massas: classificacao e adulteracao.
• Beneficiário: Gustavo Braga Sanvido
• Modalidade de apoio: Bolsas no Brasil - Doutorado