Assessment of the Quality of Sildenafil Citrate Tablets used for the Treatment of Erectile Dysfunction in Lubumbashi in the Democratic Republic of Congo

Abstract

Introduction:: The circulation of substandard medicines remains a major challenge for emerging countries, particularly in Africa and the Democratic Republic of Congo. It affects all medicines, including phosphodiesterase type 5 (PDI-5) inhibitors. To combat this scourge, this study is being conducted to assess the quality of sildenafil citrate tablets sold in Lubumbashi (southeastern Democratic Republic of Congo). It involves examining samples of the targeted product purchased from local suppliers. Methods:: Visual inspection, mass uniformity, mass variation, identification, sildenafil citrate assay, and dissolution were used to evaluate the quality of sildenafil samples collected from the market. The active ingredient was assayed using a validated UV-vis spectrophotometric method. The statistical method of factors f1 and f2 was used to compare the dissolution profile of generics with that of the original. Results:: Fourteen samples were taken from fourteen wholesale establishments. Non-compliance was observed in the dissolution test and dosage. Only one sample, or 14.3 %, showed dissolution like the original. About dosage, 43 % of the fourteen samples analyzed were non-compliant. Discussion:: The dosage of sildenafil citrate showed a variation from 94.8 % to 107.4 %. The range of 95.0 to 105.0 % has been specified for the sildenafil citrate molecule in several studies. Conclusion:: The study provided worrying data on sildenafil citrate marketed in Lubumbashi, DRC. The competent authority is called upon to make efforts to guarantee the quality of medicines consumed in the Democratic Republic of Congo.