Determination of related substances in Ceftizoxime Sodium for injection by HPLC

Objective To establish a method for the determination of related substances in Ceftizoxime Sodium for injection by HPLC. Methods The determination was carried out on Agient Eclipse C18 column(250 mm × 4.6mm,5 μm) with the mobile phase containing acetonitrile-buffer solution(pH 3.6)(dissolve citric acid monohydrate 1.42 g and disodium hydrogen phosphate dodecahydrate 2.31 g in water and diluted to 1 000 mL) with gradient elution. The detective wavelength was set at 254 nm. The temperature of column was set 40 ℃. The flow rate was 0.8 mL/min with injection volume of 20 μL. Results The linearity range of ceftizoxime sodium was 0.24 — 14.52 μg/mL(r=1.000 0),and LOD was 0.03 μg/mL. Conclusion The method is simple and selective to be used for the quality control of Ceftizoxime Sodium for injection products effectively.