Sildenafil Determination by Using UPLC in Different Italian Viagra Tablets

Abstract

Aims: The introduction of generics drugs has brought the need for more control of their quality and purity. In Italy from June 23, 2013 the Pfizer® has no longer the patent for the Viagra’s production and other industries produce equivalent products containing Sildenafil citrate. Study design: Thus, in this work, the chemical profiles of both Viagra Italian Pfizer® and 3 Italian commercial Sildenafil citrate tables (generic pharmaceutical manufacturers) for male erectile dysfunction were obtained by using UltraPerformanceLiquid Chromatography (UPLC). Methodology: UPLC methodology was successfully used for the assay of Sildenafil citrate in different products in Italy which are under the cover of alternative systems of medicine. Results: The results show that: i) the chromatographic profiles obtained from Italian Sildenafil citrate tablets are identical and not present other active pharmaceutical ingredients; ii) the commercial samples have a quantity of Sildenafil citrate comparable with the corresponding labelled amounts. Conclusion: The UPLC method can be used for determination of Sildenafil citrate tables marketed by generic pharmaceutical manufacturers in Italy.