Quality Assessment Of Different Brands Of Diclofenac Tablets Marketed In Florin Metropolis: A Pharmaceutical And Public Health Perspective

Authors

  • Abdullahi S. T. Department of Pharmaceutical Chemistry,
  • Olanipekun O. C. Department of Pharmaceutical and Medicinal Chemistry,
  • Njinga N. S. Department of Pharmaceutical and Medicinal Chemistry,
  • Eniayewu O. I. Department of Pharmaceutical and Medicinal Chemistry,
  • Bamidele O. D. Department of Pharmaceutical and Medicinal Chemistry,
  • Bakare-Odunola M. T. Department of Pharmaceutical and Medicinal Chemistry,
  • Shittu A. O. Department of Pharmaceutics and Industrial Pharmacy,
  • Soyinka J. O. Department of Pharmaceutical Chemistry,

Keywords:

diclofenac tablets, spectrophotometric analysis, quality, substandard, falsified medicines

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 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.

Author Biographies

Abdullahi S. T. , Department of Pharmaceutical Chemistry,

Obafemi Awolowo University, lie-lfe, Nigeria

Olanipekun O. C. , Department of Pharmaceutical and Medicinal Chemistry,

University of Ilorin, Ilorin, Nigeria

Njinga N. S. , Department of Pharmaceutical and Medicinal Chemistry,

University of Ilorin, Ilorin, Nigeria

Eniayewu O. I. , Department of Pharmaceutical and Medicinal Chemistry,

University of Ilorin, Ilorin, Nigeria

Bamidele O. D. , Department of Pharmaceutical and Medicinal Chemistry,

University of Ilorin, Ilorin, Nigeria

Bakare-Odunola M. T. , Department of Pharmaceutical and Medicinal Chemistry,

University of Ilorin, Ilorin, Nigeria

Shittu A. O., Department of Pharmaceutics and Industrial Pharmacy,

University of Ilorin, Ilorin, Nigeria

Soyinka J. O., Department of Pharmaceutical Chemistry,

Obafemi Awolowo University, lle-lfe, Nigeria

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Published

2020-06-01

How to Cite

S. T. , A., O. C. , O., N. S. , N., O. I. , E., O. D. , B., M. T. , B.-O., … J. O., S. (2020). Quality Assessment Of Different Brands Of Diclofenac Tablets Marketed In Florin Metropolis: A Pharmaceutical And Public Health Perspective. The Nigerian Journal of Pharmacy, 54(2), 49–65 | https://doi.org/10.51412/psnnjp.2020.4. Retrieved from https://www.psnnjp.org/index.php/home/article/view/60