Product quality evaluation of marketed veterinary Ivermectin formulations in Addis Abeba

Abstract

Objectives: To assess the prevalence of substandard products, a quality study based on the United States Pharmacopeia (USP) standards was conducted on the veterinary medicinal product ivermectin.Methods: From September 2020 to January 2021, a cross-sectional quality analysis was carried out on 19 samples of pharmaceutical products. These samples were obtained from all veterinary retail outlets in Addis Ababa, Ethiopia. The analysis included organoleptic assessment for packaging-related information and physical appearance, as well as high-performance liquid chromatography (HPLC)-based physicochemical analysis for identity, assay, packaging uniformity, and HLB ratio. The procedures followed were in accordance with the USP recommendations. The quality analysis took place at the national veterinary drug quality test center.Results: The quality analysis revealed the presence of substandard products in terms of packaging uniformity (16.7%), API assay (15.8%), and filling to a volume (16.67%). However, both sampled products demonstrated the expected API, recommended physical appearance, and consistent packaging information. The prevalence ratio values for all H1B1a/(H1B1a+H1B1b) chemical species were greater than 0.95.Conclusion: The findings from this study clearly indicate the alarming presence of substandard veterinary pharmaceutical products. This highlights the need for strengthening the regulatory surveillance system.

Keywords

• ivermectin
• quality analysis
• substandard drugs
• ethiopia