Identification and Quantification of An Adulterant in A Dietary Supplement Marketed For Sexual Enhancement - Identification and Quantification of An Adulterant in A Dietary Supplement Marketed For Sexual Enhancement - Open Access Pub

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. DOI10.14302/issn.2328-0182.japst-18-2344 Since 1998, the use of dietary supplements (DS) in Argentina has been regulated in the “Código Alimentario Argentino” (CAA) (Law no. 18284). DS are defined as “products used to increase the regular dietary intake, supplementing the incorporation of nutrients in the diet of healthy people who, in the absence of pathological conditions, present an unmet dietary need”. In terms of composition, DS should provide nutrients such as proteins, vitamins, minerals, lipids, carbohydrates, and fibres. Some botanicals or extracts thereof can also be used 1. Initially, 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. In 2001, ANMAT, the food and drug regulatory agency of Argentina, authorised a total of 35 herbs that can be incorporated in DS (ANMAT Res. no. 1637/2001). These herbs are Astragalus membranaceus, Ginkgo biloba, Panax ginseng, Passifloraincarnata, Valeriana officinalis, and Equisetum arvense, among others. These herbs are only permitted if accompanied by vitamins, minerals,