Quality evaluation of registered brands of amoxicillin capsules sold in pharmacies in Kampala, Uganda

Background: Amoxicillin is a commonly used antibiotic, but substandard medicines remain a major public health concern in low- and middle-income countries. Methodology: This study assessed the quality of registered amoxicillin capsule brands sold in pharmacies in Kampala, Uganda, for compliance with pharmacopoeial standards. Nine brands were evaluated using visual inspection, capsule measurements, weight variation, disintegration, moisture content, infrared spectroscopy for identification, assay by high-performance liquid chromatography, and dissolution testing in accordance with British and United States Pharmacopeia requirements. Results: All brands contained amoxicillin, with assay results (92.14–100.49%) within acceptable limits, and all complied with disintegration and moisture content specifications. However, two brands failed the weight variation test, while two others did not meet dissolution requirements by releasing less than 80% of the drug within 60 minutes. Overall, 22.2% of the brands were classified as substandard. In addition, similarity factor analysis showed that only half of the generic brands had dissolution profiles comparable to the innovator product. Conclusion: The findings indicate that although most amoxicillin capsules on the Ugandan market are of acceptable quality, notable quality control gaps persist, emphasizing the need for stronger regulatory oversight, improved manufacturing practices, and ongoing post-market surveillance to safeguard public health. Keywords: Amoxicillin capsules; Quality assessment; Uganda