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

Authors

Mercy Okezue, Purdue UniversityFollow
Daniel T. Smith, Purdue UniversityFollow
Kelvin Musaya, Kilimanjaro School of PharmacyFollow
Nsabo Kihore, Kilimanjaro School of PharmacyFollow
Zita Ekeocha, Purdue UniversityFollow
Timothy Nowak, Merck Biopharmaceutical CompanyFollow
Susan Roth, Merck Biopharmaceutical CompanyFollow
Mikyung Lee, Merck Biopharmaceuical CompanyFollow
Michael Stepanovic Jr., Purdue UniversityFollow
Holly L. Maize, Purdue UniversityFollow
Adebola Adekoya, United States Pharmacopoeia, Regional Office, NigeriaFollow
Stephen Byrn, Purdue UniversityFollow
Kari Clase, Purdue UniversityFollow

Abstract

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.

Recommended Citation

Okezue, Mercy; Smith, Daniel T.; Musaya, Kelvin; Kihore, Nsabo; Ekeocha, Zita; Nowak, Timothy; Roth, Susan; Lee, Mikyung; Stepanovic, Michael Jr.; Maize, Holly L.; Adekoya, Adebola; Byrn, Stephen; and Clase, Kari (2023) "Evaluating Active Content in Chloramphenicol Ophthalmic Solutions Available in a Low-Resource Setting: A Case Study," The Proceedings of the BIRS Community: Vol. 1 : Iss. 1, Article 5.
DOI: https://doi.org/10.7771/2836-5666.1006
Available at: https://docs.lib.purdue.edu/birstrp/vol1/iss1/5