Evaluating Active Content in Chloramphenicol Ophthalmic Solutions Available in a Low-Resource Setting: A Case Study

The Chloramphenicol molecule is not stable at elevated temperatures. The eye drop preparations require cold storage and this is a challenge for low-income countries. The study assessed the stability of chloramphenicol products likely stored and transported outside the recommended refrigeration temperatures. Twenty-four Chloramphenicol eye drops were randomly sampled from local medicine stores and pharmacies in Tanzania. High-pressure-liquid chromatography was used to conduct laboratory analysis to determine the content of chloramphenicol in the products. The results indicated the sampled products contained between 69.0% to 87.0% of the active ingredient; outside the Pharmacopeia limits (90.0% - 130.0%) for Chloramphenicol ophthalmic solutions. It is likely that the products were not handled to comply with the label requirement for cold storage. Therefore, a large proportion of these eye drops in low-resource settings may not have adequate content required for the product quality.