Abstract
In recent years, the consumption of dietary supplements (DS) has increased worldwide. In Argentina, approximately 14 million DS units were sold between 2015 and 2017. The adulteration of DS with active pharmaceutical ingredients or their analogues has been reported. This represents an alarming emerging risk to public health. The aim of this work was to detect the possible adulteration of a DS marketed in Argentina for the treatment of erectile dysfunction. Initially, thin layer chromatography analysis of the DS capsules content suggested the presence of a major compound. For the isolation and purification of this compound, an easy method consisted of a liquid-liquid extraction (water/CH2Cl2) followed by re-crystallisation from ethanol, is reported. Spectroscopic techniques such as mono- and bidimensional nuclear magnetic resonance, Fourier transform infrared spectroscopy and mass spectrometry allowed its identification as tadalafil. A rapid and reliable method was developed for the quantification of tadalafil in this DS by high performance liquid chromatography-mass spectrometry (HPLC-MS/MS). The mean content of tadalafil per capsule was 21.2 mg which represents a slightly higher value than that found in approved products in Argentina (5 or 20 mg per tablet). In addition, an undeclared alga was identified in the DS by microscopic techniques.
Highlights
Since 1998, the use of dietary supplements (DS) in Argentina has been regulated in the “Código Alimentario Argentino” (CAA) (Law no. 18284)
Tadalafil working standard was isolated from tablets of CialisTM (20 mg) and its identity and purity was evaluated by nuclear magnetic resonance (NMR), Fourier transform infrared spectroscopy (FT-IR) and mass spectroscopy (MS) and compared to those obtained from tadalafil pharmaceutical secondary standard from Sigma Aldrich
We have previously described the identification of aminotadalafil, a non-approved tadalafil analogue, as an adulterant in a DS marketed in Argentina for the treatment of erectile dysfunction (ED) [8]
Summary
Since 1998, the use of dietary supplements (DS) in Argentina has been regulated in the “Código Alimentario Argentino” (CAA) (Law no. 18284). DS were mainly products based on vitamins, minerals, proteins and fibre, but over the last years, and mainly in response to consumer demands, the profile of these products has changed, and other constituents such as herbal products have been incorporated. These herbs are Astragalus membranaceus, Ginkgo biloba, Panax ginseng, Passiflora incarnata, Valeriana officinalis, and Equisetum arvense, among others. These herbs are only permitted if accompanied by vitamins, minerals, carbohydrates, proteins and fibres. A wide array of DS adulterants has been reported. These substances are added to enhance the properties of the product [5, 6]
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