OBJECTIVE: To establish a method for the content determination of Esomeprazole sodium for injection. METHODS: UPLC-MS/MS was performed. The column of ZORBAX Eclipse Plus C18 with 0.1% formic acid-methanol(73 ∶ 27,V/V) at a flow rate of 0.3 ml/min, column temperature was 35 ℃, analysis time was 5 min, injection volume was 2 μl; ionization mode was positive ion mode, ion source temperature was 150 ℃, capillary voltage was 3.0 kV, cone voltage was 50 V, cone flow was 150 L/Hr, desolvation temperature was 450 ℃, desolvation gas flow was 900 L/Hr, nebuliser pressure was 7.0 Bar, parent ion scan range was 100-800 mz/mz, working mode was multiple reaction monitoring mode. RESULTS: The linear range of esomeprazole was 0.2-20.0 ng/ml(r=0.999 7); the limit of quantitation was 50 pg/ml; RSDs of precision, stability and reproducibility tests were lower than 2%; recovery was 99.93%-100.05%(RSD=0.1%,n=9). CONCLUSIONS: The method is simple and accurate, and can be used for content determination of Esomeprazole sodium for injection.
关键词
注射用埃索美拉唑钠含量测定超高效液相色谱串联质谱法
Keywords
Esomeprazole sodium for injectionContent determinationUPLC-MS/MS