Determination of Chloride, Sulfate, Trifluoroacetic acid, Phosphate, Sodium and Ammonium from Semaglutide by Ion Chromatography

A developed and validated method on Ion Chromatography for the determination of chloride, sulfate, trifluoroacetic acid, phosphate, sodium and ammonium from Semaglutide active pharmaceutical ingredient (API). It is new, simple, accurate, precise and reproducible method. This Ion Chromatography method requires high capacity columns for best resolution and peak shapes. Chloride, sulfate, trifluoroacetic acid and phosphate were separated using IonPac AS11-HC column whereas sodium and ammonium were separated using IonPac CS16 column. These anions and cations had been analysed by suppressed conductivity detection in two different channels with same IC system. This method is linear from 1.0mg/L to 100.0mg/L of chloride, sulfate, trifluroracetic acid and phosphate, whereas it is linear for 10.0mg/L to 200.0mg/L of Sodium and 0.1mg/L to 5.0mg/L of Ammonium. The limits of detection and quantification have also been established for these anions and cations. This method had been validated and shows good sensitivity, reproducibility, linerarity, specificity and robustness. Therefore, this method can be applicable for routine and regular analysis of anionic and cationic process impurities from semaglutide.