Quality assessment of different brands of diclofenac tablets marketed in Ilorin metropolis: a pharmaceutical and public health perspective.
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Date
2020
Journal Title
Journal ISSN
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Publisher
Nigerian Journal of Pharmacy. Published by Pharmaceutical Society of Nigeria.
Abstract
Background: The quality of a medicinal product is an important factor for its safety and efficacy. Poor-quality
medicines are a major impediment to improvements in public health. This study assessed the pharmaceutical
quality of different brands of diclofenac (DCF) tablets in Ilorin metropolis.
Methods: Four randomly selected brands of diclofenac potassium tablets (coded: DCF-A, DCF-B, DCF-C and DCF-D)
were obtained from pharmaceutical outlets, and quality parameters were evaluated according to Pharmacopeial
methods. The potency of tablets was determined spectrophotometrically based on the measurement of maximum
absorbance at a wavelength of 276 nm in doubly distilled water.
Results: Method validation according to the International Council for Harmonization guidelines showed acceptable
sensitivity (limit of detection of 0.3886 μg/mL and limit of quantication of 1.1775 μg/mL), precision (% relative
standard deviation range of 0.72 – 1.54), accuracy (% recovery range of 98.9 – 101.3). Average contents of active
diclofenac were 45, 98, 103 and 105% for DCF-A, DCF-B, DCF-C and DCF-D respectively. DCF-A brand was not only
substandard but falsied based on British Pharmacopoeia potency specication range of 95 – 105%.
Conclusion: A substandard and falsied brand of diclofenac tablets was detected. Drug regulatory authority must
ensure periodic post-registration surveillance of licensed pharmaceutical products marketed in the country to
secure the health and safety of the populace.
Description
Keywords
diclofenac tablets, spectrophotometric analysis, quality, substandard, falsied medicines
Citation
Abdullahi, S.T., Olanipekun, O.C., Njinga, N.S., Eniayewu, O.I., Bamidele, O.D., Bakare-Odunola, M.T., Shittu, A.O. & Soyinka, J.O. (2020). Quality assessment of different brands of diclofenac tablets marketed in Ilorin metropolis: a pharmaceutical and public health perspective. Nigerian Journal of Pharmacy. 54(2): 49-65.