Content and Uniformity of Mexican Manufactured Lovastatin and Warfarin Versus American Manufactured Lovastatin and Warfarin

Abstract

Objective: To analyze the quantity of active ingredient as well as the content uniformity of lovastatin and warfarin manufactured in Mexico as compared to the lovastatin and warfarin manufactured in the United States. Methods: High-pressure liquid chromatography assays modified from the U.S. Pharmacopoeia will be used to evaluate the amount of active ingredient found in lovastatin and warfarin manufactured in Mexico and America. Area-under-the-curve analysis was done to evaluate relative quantities of the active ingredients. Results: The amount of lovastatin found in the Mexican manufactured product was found to be 64%, and content uniformity was found to be 73%, both values are outside of the acceptable range of 90%-110% set by the USP-NF guidelines. The amount of warfarin found in the Mexican manufactured product was found to be 84% with a content uniformity of 100%. The average content value is outside of the acceptable range of 90%-110% set by the USP-NF guidelines. Conclusion: The results of this study showed that the amounts of active ingredients found in Mexican manufactured lovastatin and warfarin were significantly different from the amounts found in the American manufactured products.