Quality Assessment Of Different Brands Of Diclofenac Tablets Marketed In Florin Metropolis: A Pharmaceutical And Public Health Perspective
Keywords:
diclofenac tablets, spectrophotometric analysis, quality, substandard, falsified medicinesAbstract
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 pg/mL and limit of quantification of 1.1775 pg/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 falsified based on British Pharmacopoeia potency specification range of 95 — 105%.
Conclusion: A substandard and falsified 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.
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