A Comparative Study of the Quality of Lorazepam and Phenytoin Manufactured in Mexico and the United States

Abstract

Objectives: To determine whether the quantity of active ingredient and content uniformity of lorazepam and phenytoin manufactured in Mexico is comparable with those manufactured in the United States. Methods: A high-performance liquid chromatography (HPLC) assay based on slightly modified United States Pharmacopoeia- National Formulary (USP-NF) guidelines was used. Relative quantification of the active ingredient was accomplished using the US products as standards. The US products were assumed to contain 100% of the active ingredient. Lorazepam 1mg tablets and phenytoin 100mg capsules were tested using the assays. Results: The quantity of active ingredient in the Mexican lorazepam 1mg tablets were within the acceptable range of the USP-NF guidelines at 100%. The content uniformity was also within the acceptable range of the USP-NF guidelines at 104.6%. The quantity of active ingredient in the Mexican phenytoin 100mg capsules as well as content uniformity were also within the acceptable range of the USP-NF guidelines at 101.6% and 98.2%, respectively. Implications: The results of this study showed that lorazepam and phenytoin manufactured in Mexico were comparable to those manufactured in the US with no significant differences regarding amount of active ingredient and content uniformity.