Content Determination of Esomeprazole Sodium for Injection by UPLC-MS/MS / 中国药房

ABSTRACT

OBJECTIVE:To establish a method for the content determination of Esomeprazole sodium for injection. METH-ODSUPLC-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 2μl;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.