Abstract:

Introduction: Trimethoprim-Sulfamethoxazole (TMP-SMX) is an antibiotic of the sulphonamide group, used to treat a number of bacterial infections and parasitic infections. It is used as a prophylaxis agent for opportunistic infections in HIV patients. It is important to frequent monitor the quality of this drug post market.

Aim: The aim of this study was to evaluate the quality of different registered brands of Trimethoprim-Sulfamethoxazole tablets in Mwanza city.

Methodology: Four brands of TMP-SMX both local and imported, conveniently purchased from community pharmacies of Mwanza were in vitro quality tested using HPLC for assay and dissolution tests in the laboratories of Tanzania Medicines and Medical Devices (TMDA), Lake Zone.

Results: A total of 8 samples of different batches, each from one of the three imported brands (Unitrim, Oriprim and Betrim) and one local brand (Shetrim) were collected. Both HPLC assay test and dissolution test collected the information for Sulfamethoxazole and Trimethoprim respectively. All samples conformed to the British Pharmacopoeia specifications for HPLC assay test (90-10%) and dissolution test (≥80%).

Conclusion: All four brands of TMP-SMX, both local and imported conformed to the British Pharmacopoeia specifications for HPLC assay test (90 – 107%) and dissolution test (≥80%). Frequent post market surveillance is needed to monitor the quality of these products.