Sildenafil Determination by Using UPLC in Different Italian Viagra Tablets.

ABSTRACT

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.