Assessment of paracetamol and caffeine containing non-opioid analgesics tablets commercially available in Bangladesh
Rafica Yasmin Sumaiya, Monira Ismail Meem, Md. Mazharul Islam, Mohammad Shoeb, Md. Iqbal Rouf Mamun


Abstract:

Context: Paracetamol is widely used as an over-the-counter (OTC) drug, often combined with caffeine to enhance its activity. In Bangladesh, there are multiple brands of paracetamol and caffeine formulations, but their quality is not 
consistently assured.  
 
Objective: This study aims to evaluate the quality and quantitative assessment of sixteen different brands of paracetamol and caffeine tablets in Bangladesh. Methods: Specifically, it focuses on assessing parameters such as weight variation, moisture content, ash content, pH, and the actual doses present in the tablets. The formulations of the tablets were identified using FTIR 
spectrophotometry. Quantitative analysis of the actives (paracetamol and caffeine) was carried out using a double-beam UV-visible spectrophotometer. 
 
Results: The findings indicate that the tablets generally met quality standards. Moisture content (0.41-3.32%), ash content (0.01-1.62%), and pH (6.20 to 7.20), all are within acceptable limits. Weight variation, at 0.01-1.68%, was also below the permitted threshold of 5%. FT-IR spectroscopy confirmed the presence of both paracetamol and caffeine in all samples. The UV-visible spectrophotometric analysis revealed that the actual doses of paracetamol (335.37-536.56 mg) and caffeine (46.43-60.56 mg) per dosage were slightly lower than the labeled manufactured doses.  
 
Conclusion: The tablets generally met quality standards regarding moisture, ash, pH, and weight variation, the discrepancy between 
labeled and actual doses of paracetamol and caffeine highlights the need for improved quality control measures in the manufacturing process.

Keywords: Caffeine, Non-Opioid Analgesics, Paracetamol, Ultraviolet-Visible spectrophotometric, FT-IR