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Original Research Article | OPEN ACCESS

Comparative analysis of eight brands of sulfadoxine-pyrimethamine tablets

Michael A Odeniyi1, Olajire A Adegoke2, Remilekun B Adereti1, Oluwatoyin A Odeku1 , Oludele A Itiola1

1Department of Pharmaceutics and Industrial Pharmacy, University of Ibadan, Ibadan, Nigeria; 2Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Ibadan, Ibadan, Nigeria.

For correspondence:-  Oluwatoyin Odeku   Email: odeku@skannet.com

Published: 20 June 2003

Citation: Odeniyi MA, Adegoke OA, Adereti RB, Odeku OA, Itiola OA. Comparative analysis of eight brands of sulfadoxine-pyrimethamine tablets. Trop J Pharm Res 2003; 2(1):161-167 doi: 10.4314/tjpr.v2i1.6

© 2003 The authors.
This is an Open Access article that uses a funding model which does not charge readers or their institutions for access and distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0) and the Budapest Open Access Initiative (http://www.budapestopenaccessinitiative.org/read), which permit unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited..

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.

Keywords: Chemical equivalence, comparative study, pyrimethamine-sulfadoxine tablets

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Thompson Reuters (ISI): 0.6 (2023)
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