COMPARATIVE STUDY OF THREE BRANDS OF SLIDENAFIL CITRATE TABLETS IN SUDANESE MARKETS

Fatehalrahman F. Magbool; Mahmoud A Ibrahim; Abd Alsalam Sami; Abdrhman Mahmoud Gamil; Zuhir Osman

doi:10.22270/ujpr.v10i4.1387

Fatehalrahman F. Magbool Red Sea University, Sudan.
Mahmoud A Ibrahim College of Pharmacy, Department of Pharmaceutical Analysis, Ribat National University, Sudan.
Abd Alsalam Sami College of Pharmacy, Department of Pharmaceutical Analysis, Ribat National University, Sudan.
Abdrhman Mahmoud Gamil Department of Pharmaceutics, Faculty of Pharmacy, Al-Neelain University, Khartoum, Sudan.
Zuhir Osman Department of Pharmaceutics, Faculty of Pharmacy, University of Khartoum, Khartoum, Sudan.

10.22270/ujpr.v10i4.1387

Keywords:

Disintegration, dissolution profile, drug products, quality assessment, Sildenafil, Sudan

Abstract

Aim and Objectives: This study assessed the quality of Sildenafil citrate tablet products, whether locally produced or imported, available in the Sudanese market, aiming to determine their potential interchangeability in clinical use.

Methods: The quality evaluation of the drug products covered physical and organoleptic characteristics, along with tests for weight variation, friability, hardness, disintegration time, dissolution profile, and determination of Sildenafil content. The assay was performed using the standard HPLC method.

Results: Findings indicated that the similarity between brand E & F was noticed in color, shape, film coat and weight, brand E, friability and hardness results were acceptable, the dissolution result showed that the peak release of the drug is between 30-45 minutes, disintegration of the tablet was not faster than brand F but shorter than brand S. Brands E and S were found to be containing more that the assumed concentration of Sildenafil Citrate (50 mg).

Conclusion: The finding of this research clearly notes that the range of the active ingredient content in two brands out of the three is obviously way above limits. USP states that the tablet assay range flouts between 90-110%. Sildenafil is now widely prescribed for pulmonary hypertension in children here in Sudan, and it has been used with a high success ratio in this field, so the dosing system should be carefully measured, and without a proper Q.A, Q.C testing of the brands itself, it could lead to a very dangerous consequences.