Quality Of Sulfadoxine/Pyrimethamine Tablets Marketed In Dar Es Salaam, Tanzania

M B Jande; O Ngassapa; I O Kibwage

M B Jande Department of Clinical Pharmacology, Faculty of Medicine, Muhimbili University College of Health Scierices, P.O. Box 65010, Dar es Salaam, Tanzania.
O Ngassapa Deptartment of Pharmacognosy, Faculty of Pharmacy, Muhimbili University College of Health sciences, P.O. Box 65013, Dar es Salaam, Tanzania
I O Kibwage epartment of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Nairobi, P.O. Box 19676, Nairobi, Kenya.

Keywords: Sulfadoxine/Pyrimethamine, quality assurance

Abstract

The quality of brands of Sulfadoxine/pyrimethamine tablets, from nine different JIB manufacturers, was assessed, by determining the content of active ingredients and their dissolution profile. All nine brands complied with the USP requirement for the content of sulfadoxine and pyrimethamine. However, only four brands passed the dissolution test, which according to the USP, requires that more than 60% of each active ingredient should be in solution in 30 minutes. One brand failed the dissolution test, with respect to both active ingredients, for which only 19.9% and 56.9% of pyrimethamine and sulfadoxine, respectively, were in solution, in 30 minutes. The remaining four brands, failed with respect to pyrimethamine, for which less than 60% was in solution in 30 minutes. These findings clearly indicate that, in addition to parasite resistance to sulfadoxine/ pyrimethamine, failure of this drug combination to cure malaria could also be due to the sub-standard products available on the market. It is recommended that pharmaceutical manufacturers should ensure that their products meet the required standards by adherence to good manufacturing practice. Statutory drug control bodies should also ensure that each product, imported or locally manufactured, meets the required compendial standards before being permitted to be on the market.