QUALITY ASSESSMENT OF DICLOFENAC TABLETS MARKETED IN SAGAMU COMMUNITY, OGUN STATE, NIGERIA

Substandard and fake drugs pose significant health risk globally. As the number of diclofenac brands increases worldwide, a continuous quality control testing is necessary to maintain the consistency of the products, their effectiveness and safety of patients. This study evaluated the in vitro chemical equivalence and in vivo analgesic efficacy of five brands of diclofenac potassium. Quality control tests including weight variation, friability, hardness, disintegration, dissolution, and content purity analysis were conducted as per the British Pharmacopoeia standards. Moreover, the in vivo analgesic effect was compared via the hot-plate method. The five brands (A, B, C, D, and E) had a 100% pass rate in weight variation, friability, hardness, and disintegration tests. Brands A, C, D and E failed the dissolution test with drug release percentages of 51.2%, 52.21%, 30.53% and 46.17% at 45 minutes respectively. Brand B, on the other hand, met the official standard with a drug release of 70.44%. The content purity analysis showed that Brands A, B, C, and E met the standards of the pharmacopoeia with purities of 97%, 95.5%, 100%, and 98.5%, respectively, and Brand D failed with a purity of 75%. Despite these discrepancies, all brands demonstrated significant in vivo analgesic activity. The findings from this study highlight the significance of continuous post-market surveillance to ensure safety, efficacy and strict adherence to quality standards.