Avaliação da qualidade de citrato de sildenafila em amostras comercializadas de forma ilícita.

Abstract

Good practice for manufacturing drugs establish the minimal conditions necessary to ensure and achieve quality of pharmaceutical products. Fake and smuggled drugs are not necessarily controlled by regulating and supervising institutes, not being able this way to ensure security and effectiveness of these products. The main fake drugs, seized by the federal police, are those which contain an inhibitor of V phosphodiesterase in their composition, being sildenafil citrate the main example of pharmaco of this group. Ilegal drugs may contain alterations and falsifications with too much ingredients or insufficient amounts, mixtures of toxic , harmful or inactive substances. Despite the fact of not possesing a national pharmacy monograph for analizing the quality of sildenafil citrate, several studies of validation of analitical methodology were published, being possible observed that the main method selected among them is the high performance liquid chromatography (HPLC). The purpose of this study was to measure the quality of 4 parts of pills containing sildenafil citrate 50 mg, sold ilegally, using the high performance liquid chromatography to determinate the content and identify the active substance and uniformity of unit dose. The chromatographic conditions for the method were: column C18 (3,9mm x 300mm;10 um), UV detector in 240nm, mobile phase containing ammonia acetate and acetonitrile (1:1 v/v), flow rate 1,0 mL/min, sample solution and standard at concentration of 0,1mg/ml. The results were aproved by the samples analized in the assessed parameters, however this isolated case does not certificate for all ilegal drugs containing sildenafil citrate.