Quality Control Parameters of Antihypertensive Medications Marketed in Eastern Ethiopia: Amlodipine Besylate and Enalapril Maleate Tablets

Abstract

Substandard medications have a negative impact on treatment outcomes.To get the desired therapeutic effect, drugs need to have the required pharmaceutical properties and the right amount of the active pharmaceutical ingredient.Thus, this study aimed to evaluate the quality control parameters of different brands of amlodipine besylate and enalapril maleate tablets marketed in Harar City, Eastern Ethiopia.Three brands of amlodipine besylate and enalapril maleate tablets were procured from community pharmacies in Harar City, Eastern Ethiopia.Weight variation, tablet breaking force, friability, disintegration, assay, and dissolution tests were carried out to evaluate quality control parameters of amlodipine besylate and enalapril maleate tablets.Corresponding results were compared with United States Pharmacopeia (USP) standards.All the brands of amlodipine besylate and enalapril maleate tablets met the USP specifications.Weight variation, breaking force, friability, drug content, and disintegration time for amlodipine besylate tablets ranged from -3.26-4.06%,35.06-49.13N, 0.11-0.49%,97.98-99.97%,and 0.12-0.68minutes, respectively.Weight variation, breaking force, friability, drug content, and disintegration time for enalapril maleate tablets ranged from -2.97-5.93%,77.86-156.49N, 0.08-0.62%,97.98-100.59%,and 2.63-9.03minutes, respectively.The dissolution profiles of all brands of both antihypertensive medications were within the acceptable range.All brands of amlodipine besylate and enalapril maleate tablets available in Harar City fulfilled the USP requirements and could be used interchangeably in clinical practice.