New HPLC/UHPLC Assay Methods for Impurities in Tetracycline

摘要

Tetracycline (TC), a common antibiotic used to treat urinary tract infections, acne, gonorrhea, and other conditions, yields a toxic degradation product, 4-epianhydrotetracycline (EATC). General Chapter 226 of the U.S. Pharmacopeia and National Formulary (USP-NF), referred to by monographs for epitetracycline and drug products containing tetracycline hydrochloride (TC-HCI), prescribes an antiquated assay for EATC impurity in TC. This method uses a self-packed column eluted with chloroform. The EATC impurity elutes as a yellow band and is detected by its visible absorbance.