A Comparison of Content and Quality of Atenolol and Captopril Manufactured in Mexico and the United States

Abstract

Objectives: To determine whether the quantity of active ingredient and content uniformity of atenolol and captopril manufactured in Mexico are comparable with those manufactured in the United States. Methods: An adapted United States Pharmacopoeia-National Formulary (USP-NF) guideline was utilized for a high-performance liquid chromatography (HPLC) assay to quantify the active ingredient of each medication. The US products were considered to contain 100% of the active ingredient, with acceptable variance range of 90-110%. Atenolol 50 milligrams (mg) and captopril 50 mg tablets, manufactured from either Mexico or US, were tested in this comparative study. Results: Quantification of active ingredient in Mexican captopril 50 mg tablets were within the acceptable range of the USP-NF guidelines at 94.2%. The content uniformity was also within the acceptable range of the USP-NF guidelines at 99.0%. The quantity of active ingredient in the Mexican atenolol 50 mg tablets, as well as content uniformity, was also within the acceptable range of the USP-NF guidelines at 110.0% and 95.0%, respectively. Implications: The results of this study showed that captopril and atenolol manufactured in Mexico were comparable to those manufactured in the US with no significant differences regarding amount of active ingredient and content uniformity.