Comparative assessment of the physico-chemical properties and in-vitro biovalability of co-trimoxazole tablets marketed in Nigeria
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Date
2015
Authors
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Journal ISSN
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Publisher
Obafemi Awolowo University
Abstract
This study investigated the in-vitro bioavailability of some brands of co-trimoxazole tablets in Nigeria and determined the prevalence of fake or substandard co-trimoxazole tablets with a view to providing information on the quality of co-trimoxazole tablets marketed in the country.
Twenty different brands of co-trimoxazole tablets marketed in the country were obtained from retail outlets in Ile-Ife. Basic information such as batch number, NAFDAC registration number, manufacturer’s address, production and expiry dates were documented and each brand was tested for weight uniformity. The components of each brand were identified by thin layer chromatography and their percentage content were determined by the British Pharmacopoeia (BP, 2010) method, in which sulphamethoxazole was determined by titrimetry and trimethoprim by UV-spectrophotometry. Further assessment of the active ingredients was undertaken using a High Performance Liquid Chromatographic (HPLC) method for the determination of the contents and dissolution profile of each sample using the United States Pharmacopoeia (USP, 2009) monograph. The results of assay using the BP and HPLC methods were compared using Student’s t-test while ANOVA was used to compare the differences in the in-vitro release pattern of the tablets.
Only fourteen of the samples conformed to the weight uniformity requirements specified in the BP while the active ingredients, sulphamethoxazole and trimethoprim, were present in only eighteen of the samples. The assay results showed that the samples contained between 54.85 % and 103.37 % of sulphamethoxazole and between 0.24 % and 106.67 % of trimethoprim using the BP method. However, the HPLC method showed that the samples contained between 92.61 % and 99.23 % of sulphamethoxazole and between 94.99 % and 103.26 % of trimethoprim. The dissolution tests showed that between 3.80 % and 82.25 % of sulphamethoxazole were dissolved in 60 min while 17.04 % and 101.26 % of trimethoprim were dissolved. Only seven of the samples released more than the required amount of trimethoprim after 60 min while only three released more than the required amount of sulphamethoxazole. A non-significant difference (p>0.05) was observed between the BP method and the HPLC method while the release pattern of the drug showed that the brands were not equivalent with respect to their in-vitro release profile as there was a significant(p<0.05) difference in the release profile at the two time points (10 min and 60 min).
The study concluded that there is a prevalence of fake and substandard co-trimoxazolein the Nigerian Pharmaceutical market.
Description
xii,107
Keywords
Comparative Assessment, Co-Trimoxazole Tablets, High Performance Liquid Chromatographic, United States Pharmacopoeia, Physico-Chemical Properties, Vitro Bioavailability
Citation
Betiku, O. (2015). Comparative assessment of the physico-chemical properties and in-vitro biovalability of co-trimoxazole tablets marketed in Nigeria