An assessment of the quality of various brands of paracetamol tablets sold in the Nigerian capital city

Abstract

To assess the seriousness of the global counterfeiting problem, we quantified the amount of active ingredient present in paracetamol tablets by various official and non-official methods. Eight brands of Paracetamol 500mg tablets were assessed using the quality control parameters of weight uniformity, active ingredient content, thin layer chromatography profile, disintegration tests and visual inspection. The results were subjected to statistical analysis using GraphPad PRISM. One-way analysis of variance (ANOVA) was used to examine differences between the different brands of paracetamol with Dunnett Multiple Comparisons post test analysis. In all cases, P value of <0.05 was regarded as statistically significant. The results indicated that 75% (A, B, C, F, G, H) passed the disintegration tests, 50% (A, B, D, F) fell within the pharmacopoeial standard for active ingredient content, all the brands complied with the weight variation test, identification tests, as well as falling within the Rf range on TLC spotting in comparison with the reference standard. The cumulative compliance to all of the tests for labelling, visual inspection, disintegration, presence of active ingredient, right quantity of active ingredients, and absence of contaminant spots was 37.5%. Constant monitoring with the view to check counterfeiting of medicines and compliance to required standards is emphasized.

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Keywords: Drug quality control, counterfeit medicines, paracetamol tablets, analgesic.