Comparative pharmacopoeia analysis of selected brands of diclofenac sodium tablets available in western Uganda pharmacies based on BPp 2009

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Kampala International University. School of Health Sciences
Background: Diclofenac is one of the most commonly used non-steroidal anti-inflammatory drugs (NSAIDs) for the treatment of pain, rheumatism and other inflammatory conditions.Aim: This study was aimed at investigating whether the selected brands of diclofenac sodium meet their label specifications as well as the BP 2009.Materials and Methods: Three brands of Diclofenac sodium were randomly selected in Pharmacies of Ishaka-Bushenyi Municipality, Bushenyi. A total of 20 tablets of each brand were chosen and used for this study. Quantitative test (assay) based on UV-Vis spectroscopy as well as qualitative tests (weight variation, hardness and disintegration time test) were done. Information was recorded in duplicates and analysis conducted using MS Excel 20 I 0 Version. Results: Diclofenac sodium tablets used in this study showed weight variations but there were no significant difference (P value> 0.05). Hardness test showed that brands D2 and D3 exhibited greater capability to resist breaking than D I with hardness of 784.25N, 629.12N and 427.44N respectively. The disintegration time test showed that brands D I and D2 passed the test while brand D3 failed to pass in acidic medium according to the BP limits. The calibration curve was linear with correlation coefficient (r2) of 0.9997 at concentration range of 5.00-30.00f1g/ml. According to BP specifications of 95-105%, all the free brands failed the assay with a percentage stated content of 75.8%, 89.1% and 82.1% for brands Dl, D2, and D3 respectively. Conclusion and Recommendations: Within limitations of this study, brand D3 failed the disintegration time test in acidic medium. All diclofenac sodium brands failed the assay test because of using a low sonication time for extracting the API from the drug. Further tests should be carried out to validate the sonication time against absorbance to obtain an optimum time for extracting the API from the drug.
A Research Report Submitted to the School of Pharmacy in Partial Fulfillment of the Requirement for an Award of Bachelor of Pharmacy Degree of Kampala International University
Comparative pharmacopoeia, Diclofenac sodium tablets, Western Uganda pharmacies, BPp 2009