The increasing prevalence of counterfeit and substandard pharmaceutical products poses a significant global health challenge. Given the multitude of diclofenac brands available in the market, ensuring their quality, safety, and efficacy through rigorous quality control testing is essential to safeguard public health and maintain therapeutic reliability. This study aimed to evaluate the in-vitro chemical equivalence and in-vivo analgesic efficacy of diclofenac potassium tablets (50 mg) across five different brands. Comprehensive quality control tests, including weight variation, friability, hardness, disintegration, dissolution, and content purity analysis, were performed in accordance with the British Pharmacopoeia standards. The in-vivo analgesic activity was assessed using the hot plate method. All five brands (A, B, C, D, and E) achieved a 100% pass rate in weight variation, friability, hardness, and disintegration tests. However, 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, while Brand B met the official standard with a drug release of 70.44%. Content purity analysis revealed that Brands A, B, C, and E conformed to the pharmacopoeia standards, with percentage purities of 97%, 95.5%, 100%, and 98.5%, respectively, while Brand D failed with a content purity of 75%. Despite these variations, all brands demonstrated significant analgesic activity in vivo, indicating potential therapeutic efficacy. The study highlights the necessity for continuous post-market surveillance and strict compliance with quality standards to ensure the safety, efficacy, and reliability of pharmaceutical products.
Kasim et al. (Mon,) studied this question.