Post-Marketing Quality Control of Different Brands of Paracetamol and Paracetamol Plus Caffeine Tablets Available in Libyan Markets

Paracetamol (PA) is a widely used non-prescription analgesic and antipyretic medicine. This active pharmaceutical ingredient (API) available alone or in a combination formula as with caffeine (CA). Hence, it is essential to evaluate and compare the quality control parameters for different brands of paracetamol and paracetamol+caffeine tablets in order to assess their effectiveness. This study tested six tablets’ brands have both formulations, which are popular brands available in Tripoli retail pharmacies. Physical and chemical parameters were examined as a post marketing evaluation. The chemical tests included identification by Fourier-transform infrared (FTIR) spectroscopy and assay of drug content using UV-Vis spectroscopy for tablets of paracetamol labeled with A1, B1 and C1. However, physical analysis done for both brands, that containing paracetamol only (A1, B, and C1) and tablets of paracetamol plus caffeine (A2, B2 and C2), which included evaluation of appearance, weight variation, hardness, disintegration time and dissolution test. The results obtained showed that all the brands showed acceptable parameters according to Pharmacopeial specifications, and showed diverse physical properties. All brands demonstrated sufficient mechanical strength to resist fracture and crumbling. Additionally, samples were in compliance with the specifications of disintegration time and weight variation test. However, the chemical testing for the percent content according to BP2008 showed that product B1 was not comply with pharmacopoeia specifications with lowest API content of 91.2%. On the other hand, dissolution test revealed that the sample A2 (99%), C2(100%) paracetamol/caffeine had better release at 40 mints than brand A1(90%), C1(96%) tablets containing paracetamol only. Whereas, brands B2 (92.2%) paracetamol/caffeine tablets dissolved in slower rate compared with brand B1(92.76%) containing paracetamol alone. The results of this study indicated that the brands of Paracetamol and paracetamol combined with caffeine tablets available in the Tripoli drug market cannot be used interchangeably.