Comparative analysis of eight brands of sulfadoxine-pyrimethamine tablets

Abstract

Purpose: The aim of the present study is to investigate the physicochemical equivalence of eight brands of tablets containing sulfadoxine-pyrimethamine (antimalarial drug combination) sourced from different retail Pharmacy outlets in the Nigerian market. Method: The quality and physicochemical equivalence of eight different brands of sulfadoxine-pyrimethamine combination tablets were assessed. The assessment included the evaluation of uniformity of weight, friability, crushing strength, disintegration and dissolution tests as well as chemical assay of the tablets. Results: All the eight brands of the tablets passed the British Pharmacopoeia (BP) standards for uniformity of weight, disintegration and crushing strength. Three of the eight brands failed the friability test. One of the brands did not comply with the standard assay of content of active ingredients while another brand did not comply with the USP specifications for dissolution test for sulfadoxine-pyrimethamine tablets. There were no significant differences in the amounts of pyrimethamine and sulfadoxine released from the different brands (P>0.05). Conclusion: Only three brands (registered by NAFDAC) out of the eight brands of sulfadoxine-pyrimethamine tablets that were analysed passed all the BP quality specifications and were physically and chemically equivalent. This study highlights the need for constant market monitoring of new products to ascertain their equivalency to the innovator product. (10 refs.)