Content Determination of Esomeprazole Sodium for Injection by UPLC-MS/MS
10.6039/j.issn.1001-0408.2016.27.36
- VernacularTitle:UPLC-MS/MS法测定注射用埃索美拉唑钠的含量
- Author:
Xuening ZHANG
;
Limin ZHANG
;
Jing ZHANG
;
Chunhua ZHOU
;
Qian ZHANG
;
Zhifei HOU
- Publication Type:Journal Article
- Keywords:
Esomeprazole sodium for injection;
Content determination;
UPLC-MS/MS
- From:
China Pharmacy
2016;27(27):3852-3854
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To establish a method for the content determination of Esomeprazole sodium for injection. METH-ODS: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 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.
