RESUMO
@#Established liquid chromatographic method for determination of desloratadine and its impurities by DOE. The separation was achieved by using a reversed phase chromatographic column(ODS, 250 mm×4. 6 mm, 4 μm)with gradient eluent composed of ethanol-0. 003 mol/L sodium dodecyl sulfate aqueous solution(dissolve 0. 570 sodium dodecyl sulfate in water, add 0. 5 mL trifluoroacetic acid and dilute to 1 000 mL with water)(43 ∶57)at a wavelength of 280 nm. The sample size was 40 μL, column temperature was set at 35 °C and flow rate of mobile phase was 1. 5 mL/min. A method for determination of desloratadine and its impurities of process and degration was established. The developed method is sensitive, convenient, and can control the drug quality efficiently.
RESUMO
To enhance the quality control of tebipenem pivoxil and establish its quality criteria,the synthetic route of tebipenem pivoxil was analyzed and five related substances (P1,P2,P6,P8 and P9)were synthesized and characterized by 1H NMR and MS.The purities of the related substances were over 95% via HPLC detec-tion.The target compounds can be used as the reference of the related substances in the quality control of tebi-penem pivoxil.The starting materials were cheap and easy to obtain;the reaction conditions were mild.