identification And Quantification Of An Adulterant In A Dietary Supplement Marketed For Sexual Enhancement.

REDKO F; FLOR S.; LUCANGIOLI S.; ULLOA J.; RICCO R.; FERNANDEZ C.; SAMBROTTA L.; MUCHETTI L.

Journal of Advanced Pharmaceutical Science And Technology

oap

Año: 2018 vol. 1 p. 25 - 33

2328-0182

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.Flavia Redko1, Sabrina Flor2, Silvia Lucangioli2, Jerónimo Ulloa1, Rafael Ricco3, Claudio Fernández4, Luis Sambrotta4, Liliana Muschietti1,*1Universidad de Buenos Aires, Cátedra de Farmacognosia, Facultad de Farmacia y Bioquímica (UBA), IQUIMEFA (UBA-CONICET), Buenos Aires, Argentina2Universidad de Buenos Aires, Facultad de Farmacia y Bioquímica, Departamento de Tecnología Farmacéutica, Buenos Aires, Argentina and Consejo Nacional de Investigaciones Científicas y Tecnológicas, CONICET, Argentina.3Universidad de Buenos Aires, Cátedra de Farmacobotánica, Facultad de Farmacia y Bioquímica, Buenos Aires, Argentina.4Instituto de Investigaciones para el Descubrimiento de Fármacos de Rosario (IIDEFAR-CONICET-UNR and Laboratorio Max Planck de Biología Estructural, Química y Biofísica Molecular de Rosario (MPLBIOR-UNR-SOCIEDAD MAX PLANCK)DOI : 10.14302/issn.2328-0182.japst-18-2344