Quality evaluation of different brands of azithromycin tablets Marketed in adama, and modjo town of east shoa zone, oromia Regional state, ethiopia

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)