Determination related substances of rabeprazole sodium enteric-coated pellets by HPLC
- VernacularTitle:HPLC法测定雷贝拉唑钠肠溶微丸的有关物质
- Author:
Yan MA
;
Yuan WANG
;
Ruimiao CHANG
;
Aiguo ZENG
;
Qiang FU
- Publication Type:Journal Article
- Keywords:
rabeprazole sodium enteric-coated pellets;
related substances;
HPLC
- From:
Chinese Journal of Biochemical Pharmaceutics
2015;37(4):165-168
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish an HPLC method for the determination of related substances of rabeprazole sodium.Methods The determination was performed on a Xtimate C18 column.The mobile phase consisted of 2 g/L ammonium acetate-acetonitrile (95:5)and 2 g/L ammonium-methanol(15:85), with linear gradient elution and the flow rate of 1.0 mL/min.Detection wavelength was 290 nm.Results Related substances were completely separated from the main constituent.The limit of detection of rabeprazole was 0.25 ng and the limit of quantification was 0.75 ng,which were 0.01% and 0.03% of test sample and met the detection.With the selected solvents, principal component could be extracted efficiently and good stability.The sample solution was not stable at room temperature.Conclusion The method is simple, rapid and accurate, and can be used to control the quality of rabeprazole sodium enteric-coated pellets.
