ABSTRACT
Diclofenac sodium is a non-steroidal anti-inflammatory drug (NSAID), which is used for the management of general body inflammation, pain, stiffness and rheumatoid/non-rheumato id arthritis. There exist several brands of the drug in the Nigerian drug market which may or may not be the same in terms of quality and efficacy, hence the need to undertake quality control checks to ascertain the pharmaceutical quality of different multisource brands of the drug. Aims and objective: The aim of this study is to employ specific quality control parameters to evaluate and establish the pharmaceutical quality of ten (10) available brands of Diclofenac sodium in Benin City, Edo State, Nigeria. Methods: Ten (10) different brands of Diclofenac sodium of different strengths (50mg and 100mg) were purchased from registered pharmaceutical shops across the four local government areas of Benin City, Edo State and subjected to preliminary examination of their organoleptic properties such as colour, shape, presence or absence of surface coating and manufacturer’s label information (label strength, batch number, NAFDAC registration number, date of manufacture, date of expiration and manufactures addresses).Thereafter, physicochemical evaluations such as weight uniformity, content uniformity, hardness, friability, disintegration and in-vitro dissolution tests were performed in accordance, with the specifications of the British and United States pharmacopoeias. The results obtained were subjected to statistical analysis to establish their reliability and significance. Results and Discussion: From the results obtained from the study, it can be seen that all ten (10) brands of Diclofenac sodium employed in the study passed the weight uniformity test while Diclo 1, 2 and 8 failed the test for hardness as they refuse to fracture at maximum pressure. Diclo xiii 2, 3 and 10 failed the disintegration test as they exceeded the specified limit of 30 minutes. All ten (10) brands passed the test for friability, while Diclo 4 failed the uniformity of content test. Conclusion: from the study, it can be concluded that regular quality assurance checks are essential for ascertaining the quality of pharmaceutical formulation of commercially available in the market with particular reference to Diclofenac sodium.
