Determination of Related Substances in Pantoprazol Sodium Enteric-coated Capsules by HPLC with Gradi-ent Elution / 中国药师

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.