Application Note: New HPLC and UHPLC Assay Methods for Tetracycline Hydrochloride and 4-Epianhydrotetracycline Hydrochloride Impurity in Tetracycline Drug Products
12 January 2012
This note demonstrates both HPLC and UHPLC methods that can be used to assay tetracycline (TC) and 4-epianhydrotetracycline (EATC) in a TC-hydrochloride (HCl) capsule. The results from both methods meet or exceed the criteria in the appropriate United States Pharmacopeia (USP) monographs. Both methods are faster and show higher resolution than the current methods. They also generate less waste and use less hazardous organic solvents.