Quality Assessment of Fifteen Brands of Paracetamol Injections Marketed in Lagos, Nigeria
DOI:
https://doi.org/10.51412/psnnjp.2024.27Keywords:
Paracetamol injection, sterility test, quality, assay of active ingredient, NigeriaAbstract
Background: Paracetamol injection is a widely used medication for the management of pain and fever in healthcare settings. Ensuring the quality and safety of pharmaceutical products is essential to protect public health, so there is need to investigate the quality of these Pharmaceutical preparations in Lagos, Nigerian drug market in compliance with international standards and guidelines.
Method: Fifteen brands of paracetamol injections were sourced from registered pharmacies in Lagos. The sampled products were subjected to a comprehensive quality assessment using standard protocols, including testing for the presence of specified indicator pathogens using compendial procedures like sterility testing and assessment of active pharmaceutical ingredient (API) content
through high-performance liquid chromatography (HPLC).
Results: Results from the study indicated that 86.67 % of the paracetamol injection samples have the Active Pharmaceutical Ingredient (API) content within the acceptable limit of the United States Pharmacopoeia (USP) 2018, but 13.33 % of the paracetamol injection samples were found to be above the maximum acceptable limit. The sterility test results showed that none of the paracetamol injections samples recorded microbial load above the limit of USP.
Conclusion: The findings of this study highlight potential quality issues in the paracetamol injection products marketed in Lagos, Nigeria. Further investigations and continuous monitoring by regulatory authorities are recommended to ensure the consistent supply of safe and effective paracetamol injection formulations to healthcare providers and patients in Lagos and beyond.
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