Determination of Related Substances of Cefmenoxime Hydrochloride Drug Substance and Injection by UPLC

OBJECTIVE To establish UPLC for the determination of related substances of cefmenoxime hydrochloride drug substance and injection. METHODS The column was Zorbax XDB C₁₈(2.1 mm×100 mm, 3μm). The mobile phase consisted of water-acetic acid-acetonitrile(85:1.7:15)(A) and water-acetic acid-acetonitrile(50:1.7:50)(B) with gradient program. The column temperature was 30℃. The flow rate was 0.6 mL·min^-1 and the detection wavelength was 254 nm. RESULTS Cefmenoxime hydrochloride could be completely separated from its intermediates and by-products. The RSD of related substances precision was 2.5%, the detection limit was 0.001-0.08 μg·mL^-1. CONCLUTION The method is rapid, simple, sensitive, reproducible and better than the current standard method.