ABSTRACT
Purpose: Paracetamol also known as Acetaminophen, is widely accepted as an effective and inexpensive treatment for pain and fever relief in various patients. This has resulted in increased manufacturing and usage of various brands of the tablets in Nigeria. Therefore, there is the need to routinely assess the pharmaceutical quality of the available brands of the tablets to reduce the manufacture of counterfeit, substandard or adulterated products. This study seeks to investigate the pharmaceutical quality of commercially available brands of paracetamol tablets in the three senatorial disticts of Edo State, Nigeria.
Method: Eighteen (18) brands of Paracetamol 500mg tablet purchased across the three senatorial districts in Edo State were evaluated for their uniformity of weight, crushing strength, friability, disintegration and dissolution tests following official pharmacopoeial protocols. Content of active pharmaceutical ingredient and the presence of p-aminophenol was determined using Uv-visible spectrophotometry.
Results: All brands were elegantly labelled and packaged and all had NAFDAC registration number. All brands were within their shelf lives. The tablets samples from the different districts passed the weight variation test, friability tests (less than 1.0%), hardness test (6.8-12.12 kg). All brands from the various districts satisfied the BP, USP requirements for disintegration time test (within 15 minutes) and dissolution test (≥70% within 30 minutes) except five brands across the three districts. All the brands met compendial specifications with their content of active and recorded no presence of 4-aminophenol in their tablet dosage forms.
Conclusion: According to the result gotten from the study, some of the brands across the three senatorial districts of Edo State failed the quality assurance test. There is the need to routinely and continuously carry out sentinel market surveillance of pharmaceutical drug products in Nigeria
