Abstract:
Background: Azithromycin is therapeautically relevant macrolide antibiotic registered in
essential medicines list of World Health Organization. The fact that pharmaceutical product is
selected as an essential medicine doesn't mean that it is of good quality. Hence, a continuous
quality evaluation of the drug should be mandated to verify that the right medication is available
in the market.
Objective: To evaluate the quality of different brands of Azithromycin Tablets marketed in
Adama, and Modjo town of East Shoa Zone, Oromia Regional State, Ethiopia.
Methods: A total of six different brands of Azithromycin tablets were collected from Adama
and Modjo towns of East Shoa zone, Oromia regional state, Ethiopia. The experimental part of
the study was undertaken in Ethiopian Pharmaceutical Company Drug Quality Control
Laboratory (EPHARM) from July to September 2021. A Quality control test (visual inspection,
thickness, diameter, hardness, friability, weight variation, disintegration, assay, and dissolution)
was carried out by the manufacturers methods, United States Pharmacopeia and the WHO
inspection tool (Visual inspection). For statistical and graphical analyses of analytical data
obtained from the experimental findings, Microsoft Excel-2010, SPSS version-20, and the
KinetDS 3.0 software program were utilized. The Microsoft excel was used to draw the
calibration curve of the Working standard, and the graph of time dependent dissolution profiles
of the drug as well as used to determine Mean±SD. All the quality control parameters under the
study were compared by one way ANOVA (P<0.05).The in vitro dissolution profiles of the
different brands were also compared statistically using post-hoc dunnett test (p<0.05), model-
independent, and model-dependent approaches. The KinetDS 3.0 software program was used to
evaluate the release of drug substances from the dosage form.
Results: In this study, a total of six different brands of Azithromycin tablets were included. All
of the evaluated brands agreed with WHO visual inspection tool for physical characteristics,
packaging, and pharmaceutical labeling requirements. All of the tablets achieved the thickness
(5.3±0.02mm-6.9±0.03mm), and diameter (16.7±0.09mm-20.2±0.02mm) specifications of the
allowed standard deviation (±5%) the manufacturer specification. All brands agreed with the
minimum hardness test (15.96±1.1kpa-27.5±0.6kpa) requirements of 12Kpa. The friability result
(0.004%-0.04%) revealed an acceptable percentage weight loss <1% as per USP. All samples
showed acceptable weight variation as none had a percent deviation>5% and none by more than
10% as stipulated by USP (754.79±1.8mg-942.5±0.5 mg)
