Sildenafil Determination by Using UPLC in Different Italian Viagra Tablets
Nicola Giarretta
Department of Environmental, Biological and Pharmaceutical Sciences and Technologies, Second University of Naples, Via Vivaldi 43, I-81100 Caserta, Italy
Maria C. Mezzacapo
Department of Environmental, Biological and Pharmaceutical Sciences and Technologies, Second University of Naples, Via Vivaldi 43, I-81100 Caserta, Italy
Antonella M. A. Di Giuseppe
Department of Environmental, Biological and Pharmaceutical Sciences and Technologies, Second University of Naples, Via Vivaldi 43, I-81100 Caserta, Italy
Nicola Landi
Department of Environmental, Biological and Pharmaceutical Sciences and Technologies, Second University of Naples, Via Vivaldi 43, I-81100 Caserta, Italy
Martina Lippert
Department of Environmental, Biological and Pharmaceutical Sciences and Technologies, Second University of Naples, Via Vivaldi 43, I-81100 Caserta, Italy
Antimo Di Maro *
Department of Environmental, Biological and Pharmaceutical Sciences and Technologies, Second University of Naples, Via Vivaldi 43, I-81100 Caserta, Italy
*Author to whom correspondence should be addressed.
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.
Keywords: Chemical profile, UPLC, pharmaceutical preparations, sildenafil, stress testing, Viagra