Determination of S-Omeprazole Sodium and the Related Substances by RP-HPLC
- VernacularTitle:RP-HPLC法测定S-奥美拉唑钠及其有关物质的含量
- Author:
Xiao HU
;
Xiaohai TANG
;
Yongmei XIE
;
Dan YANG
;
Xiaofang HUO
;
Ai LIU
;
Jingping HOU
;
Hang SONG
- Publication Type:Journal Article
- Keywords:
RP-HPLC;
S-omeprazole sodium;
Content determination;
Related substances
- From:
China Pharmacy
2005;0(22):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To establish an RP-HPLC method for content determination of s-omeprazole sodium and its related substances.METHODS:The separation of s-omeprazole sodium and the related substances was carried out on a Phenomenex Luna C18 column,the mobile phase consisted of methanol-0.033 mol?L-1 ammonium dihydrogen phosphate-triethylamine (58∶41.8∶0.2,adjusted to pH 7.0 by phosphate acid).The detection wavelength was 302 nm,the flow rate was 1.0 mL?min-1,the column temperature was 25 ℃,and the sample size was 20 ?L.RESULTS:The linear range of omeprazole sodium was 10～500 mg?L-1 (r=0.999 7).The average recovery rate was 100.27% (RSD=0.74%).The average content of the related substances in samples was 0.42%.CONCLUSION:This method is simple,accurate,specific and applicable for content determination of s-omeprazole sodium and its related substances.
