Analysis of the Physico-Chemical Conformity of Antibiotics: Case of Amoxicillin 500 mg Capsule at the National Health Laboratory Distributed in Health Structures in Mali

Abstract

Introduction: Amoxicillin belongs to the family of β-lactams and is one of the mostly used in hospitals for the management of bacterial infections especially in Mali. It has a broad spectrum of activity from the group of aminopenicillins or aminobenzylpenicillins (group A penicillins). Microbiological and physico-chemical control has evolved with the development of biotechnology. All bacterial species or germs are affected by the phenomenon of resistance to antibacterials, which often poses real therapeutic problems. Based on previous studies in Mali, amoxicillin is still recommended in pharmacies and university hospitals to treat bacterial infections. It sometimes happens that patients are not satisfied with this amoxicillin-based prescription in our teaching hospitals. The objective of this study was to control the physico-chemical quality of amoxicillin 500 mg in capsule form.
 Methodology: This is a physico-chemical study of amoxicillin capsules dosed at 500 mg received at the National Health Laboratory in Bamako. We analyzed 10 batches of five (5) boxes (10 platelets/box) of amoxicillin. We used either HPLC, or TLC or Dissolu-test to control the quality of amoxicillin capsules for the presence of the active principle and to ensure fake amoxicillin capsules were not distributed. We used as reference, the standards contained in the pharmacopoeias in use.
 Results: The results of the physicochemical tests revealed that the samples analyzed complied with the standards of the Pharmacopoeias in use: The weight of our capsules was between 0.5g and 0.6g. All the tested samples were compliant with a disintegration time of 15 minutes at 37°C ±2°C. The peaks of standard amoxicillin and that of the tested samples appeared at substantially equal retention times, i.e. at 3.249 min and 3.248 min. respectively.
 Conclusion: Our work aimed to assess the quality of antibiotics used in Mali with the analytical means available at the LNS. All the batches of amoxicillin analyzed have not presented any cases of non-compliance so they can be distributed in health structures. This type of study should be extended to the other pharmaceutical forms of amoxicillin in the form of powders to be reconstituted dispensed in health centers in Mali.