Libyan International Medical University Journal

ORIGINAL ARTICLE
Year
: 2018  |  Volume : 3  |  Issue : 2  |  Page : 42--48

The physical, chemical, and microbiological stability of chloramphenicol ophthalmic solution


Tauwfik Mohamed Salih1, Idris Mohamed El-Mahdi2 
1 Department of Basic Sciences and Pharmaceutics, University of Benghazi, Benghazi, Libya
2 Faculty of Pharmacy, University of Benghazi, Benghazi, Libya

Correspondence Address:
Dr. Idris Mohamed El-Mahdi
Department of Pharmaceutics, Faculty of Pharmacy, University of Benghazi, P.O. Box 5341, Benghazi
Libya

Aims: The aim of this work is to “predict” the remaining shelf-life of chloramphenicol (CH) eye drops, commercially marketed, using the theoretical “Longland–Rowbotham model,”” followed by confirmation of findings by practical means. Materials and Methods: The methods used for the evaluation of CH-eye drops included the assay of the active ingredient, sterility testing, and minimum inhibitory concentration (MIC) determination using official methods during 6 months stability study at variable temperatures (4, 25°C). Furthermore, a 3-month accelerated stability study was carried out. Statistical analysis tests included Student's t-test and analysis of variance. Results: The prediction model indicated that in pessimistic conditions, the remaining shelf life was reduced to a merely 1 month following production (this is versus the 2 years expiration date given by manufacturer). However, the samples analyzed throughout a 6-month stability study revealed that storing CH solution at 4°C or 25°C does not produce any statistical difference regarding drug content, MIC, or sterility. Accelerated stability studies for 3 months period showed that only after 2 months from storage at 55°C the drug will start to degrade and a statistical difference could be observed. Conclusion: Storing CH-eye drops at room temperature for up to 6 months appears to have no effect on the stability of this antibiotic.


How to cite this article:
Salih TM, El-Mahdi IM. The physical, chemical, and microbiological stability of chloramphenicol ophthalmic solution.Libyan Int Med Univ J 2018;3:42-48


How to cite this URL:
Salih TM, El-Mahdi IM. The physical, chemical, and microbiological stability of chloramphenicol ophthalmic solution. Libyan Int Med Univ J [serial online] 2018 [cited 2021 May 14 ];3:42-48
Available from: http://journal.limu.edu.ly/article.asp?issn=2519-139X;year=2018;volume=3;issue=2;spage=42;epage=48;aulast=Salih;type=0