摘要
Objective: To analyze the related substances in Cefotiam Hydrochloride for Injection. Methods: HPLC-IT-TOF, the HPLC condition: C18 (250 mm×4.6 mm, 5 μm);temp: 30℃;mobile phase: A) 0.02 mol/L ammonium acetic;B) methanol;flow tate: 1.0 mL/min;postcoiumn split ratio: 1:1;detection: UV254;elute by linear gradient. MS parameter: ion source: ESI(+);100-1000 m/z;ionization voltage: 3.0 kV;dry gas (N2);temp: 200 ℃;emale cone voltage 30 V(1)Result: Eight related substances were separated in products, of which three were elucidated in the production, Others are degradation impurities. Conclusion: There were several related substances during production of Cefotiam.LCMS-IT-TOF provided an effective method to determine the related substances and ensure the quality and safety of the product.
