Food supplements adulteration with undeclared synthetic phosphodiesterase type-5 drugs (PDE-5) inhibitors
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abstract
The use ofplant food supplements (PFS) in developed countries is becoming increasingly
popular mostly due to the consumers' widespread idea that natural products are safer
and healthier than conventional pharmaceutical drugs [l]. However, in the last years,
several studies have been showing the existence of gaps in PFS regulation that can
result in insuíficient quality control and intentional adulteration ofthese products [2].
Among the issues that can aíFect PFS safety, the illegal addition of pharmaceutical
substances is of major concern, since unscrupulous producers can dope PFS to provide
for quick effects.
Supplements used for sexual performance improvement are among the most popular
PFS used by males. One of the major concerns in this type of product is the possible
adulteration with drugs used for the treatment of erectile dysfunction, namely
synthetic phosphodiesterase type-5 (PDE-5) inhibitor drugs, such as sildenafil,
vardenafil and tadalafil which are approved prescription drugs being marketed as
Viagra (Pfizer, USA), Levitra (Bayer Pharmaceuticals Co., Germany) and Cialis (Elli
Lilly, USA), respectively. Since these drugs can present side eífects, its illegal addition
in PFS can seriously endanger consumers' health. In particular, individuais for whom
conventional PDE-5 inhibitor drugs are contraindicated and consequently use food
supplements as an alternative maybe at risk ifthe clandestine addition ofthese drugs
occurs. In the last years, the presence ofthis type ofdrugs have been detected by FDA
in the US, and reported in food supplements commercialized in Ásia, however studies
regarding this issue in the EU are almost inexistent.
For the presented reasons, an analytical methodology based on the use of high
performance liquid chromatography coupled to a fluorescence detector in series with a
photodiode array (HPLC-FL-PDA) is proposed for the detection ofPDE-5 inhibitors,
namely sildenafil and its analogue acetildenafil, vardenafil and tadalaíil, illegally added
to supplements used for aphrodisiac purposes.
to FCT (PEst-C/EQB/LA0006/2013 and EXPL/DTP-SAP/1438/2013) and QREN
(NORTE-07-0124-FEDER-000069-CIÊNCIA DO ALIMENTO).