Abstract

Paracetamol is one of the most used analgesic and antipyretic drugs worldwide and an essential medicine in the management of pain and fever. However, variations in the quality of marketed paracetamol brands may affect their therapeutic efficacy and patient safety. This study aimed to conduct a comparative quality evaluation of different brands of paracetamol tablets marketed in Juba, South Sudan, using Thin Layer Chromatography (TLC), disintegration testing, and spectroscopic methods in accordance with British Pharmacopoeia (BP), United States Pharmacopeia (USP), and World Health Organization (WHO) standards. Five paracetamol tablet brands were randomly collected from community pharmacies and analyzed. TLC confirmed the presence of paracetamol as the active ingredient in all brands, with Rf values (0.72-0.76) matching that of the reference standard (0.74). Disintegration times ranged from 4.2 to 12.8 minutes, all within the BP limit of 15 minutes. Spectroscopic analysis showed that assay values ranged from 96.8% to 103.6%, complying with USP requirements (95-105%). Overall, all brands met pharmacopeial standards for identification, disintegration, and assay, though minor variations were observed among brands. These differences may be attributed to formulation and manufacturing practices. The findings suggest that the paracetamol brands available in Juba are of acceptable quality and safe for therapeutic use. Nevertheless, continuous post-market surveillance and regulatory monitoring are recommended to ensure sustained medicine quality, strengthen local quality control systems, and protect public health in South Sudan.

Keywords: Paracetamol, Quality evaluation, TLC, Disintegration, Spectroscopy, Juba, Pharmacopeial standards