Determination of Related Substances in Pantoprazol Sodium Enteric-coated Capsules by HPLC with Gradi-ent Elution
- VernacularTitle:HPLC梯度洗脱法测定泮托拉唑钠肠溶胶囊的有关物质
- Author:
Zhang SHU
;
Zhang YUN
- Publication Type:Journal Article
- Keywords:
Pantoprazole;
HPLC;
Gradient elution;
Related substances
- From:
China Pharmacist
2015;(6):943-945
- CountryChina
- Language:Chinese
-
Abstract:
Objective: To establish a method for the determination of the related substances in pantoprazole sodium capsules. Methods:A Kromasil C18 column (250 mm × 4. 6 mm, 5 μm) was used. 0. 01 mol·L-1 monopotassium phosphate solution (adjus-ting pH to 7. 0 with phosphoric acid)-acetonitrile was adopted as the mobile phase with gradient elution. The detection wavelength was 289 nm and the column temperature was 40℃. The injection volume was 20μl and the flow rate was 1. 0 ml·min-1 . Results:Panto-prazole sodium and its degradation substances could be well separated. The limit of detection and quantification of pantoprazole sodium was 0. 16 ng and 0. 48 ng, respectively. Conclusion:The method is simple, specific and sensitive, and can be applied to determine the related substances in pantoprazole sodium.
