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Several counterions are commonly observed to be associated with drugs to improve their physicochemical properties. Counterions belonging to both inorganic and organic nature, like, I − , NO  − , Br − , Cl − , K + , Na + , Li + , PO 3−4 , SO 2−4 , Zn 2+ , Mg 2+ , Ca 2+ , glutarate, succinate, mesylate, fumarate, citrate, oxalate and tartrate were chosen for the study. HPLC equipped with ZIC®-HILIC column with gradient elution and Corona – CAD was used to separate and detect various counterions in APIs. We have also demonstrated the application of the developed method by separating the counterions in dabigatran etexilate mesylate and sodium potassium tartrate. Further, the method was also applied to quantify the mesylate in dabigatran etexilate mesylate by CAD. This has been validated by determining system suitability, specificity, linearity, and accuracy. The linearity (r 2 &gt;0.99) of the method was observed over the range from LOQ to 200%. The concentrations were 100 µg mL −1  for LOQ and 33 µg mL −1  for LOD. RSD of LOQ was ≤ 0.20 for standard methane sulphonic acid. The results of quantification of counterion mesylate by CAD were comparable with that of potentiometric titration. The method, thus can be used for determination and identification of anions and cations with API, carbohydrates and peptides.

analytical chemistry letters

Quantification and Validation of Mesylate Ion in Dabigatran Etexilate Mesylate and Simultaneous Separation of Some Pharmaceutical Counterions using HPLC-HILIC Coupled with Corona Charged Aerosol Detector