Determination of Impurity Ions in Sulfobutyl-β-cyclodextrin by HPLC-ELSD and IC-ICD

OBJECTIVE To establish high performance liquid chromatography-evaporative light scattering(HPLC-ELSD) and ion chromatography-inhibition conductivity detection(IC-ICD) analytical method for sodium chloride, 4-hydroxy-1-butanesulfonate and bis-(4-sulfbutyl) ether disodium of sulfonbutyl-β-cyclodextrin. METHODS HPLC-ELSD method was used for assay and related subsatances test:CD-Screen-IEC column(4 mm×150 mm, 3 μm); gradient elution; flow rate:1.2 mL·min^-1. IC-ICD method was used for assay and related subsatances test:Dionex Ionpac AS19 column(4 mm×250 mm); mobile phase:30 mmol·L^-1 sodium hydroxide solution for elution; flow rate:1.0 mL·min^-1. RESULTS Two methods had good separation of components. The S/N of sodium chloride, sodium 4-hydroxy-1-butane sulfonate and bis-(4-sulfobutyl) ether disodium in HPLC-ELSD method is 0.230, 0.270 and 0.340 ng, respectively. The limit of detection of IC-ICD is 0.041, 0.027 and 0.014 ng. CONCLUSION There is no obvious difference between HPLC-ELSD and IC-ICD in three impurities content determination of sodium chloride, 4-hydroxy-1-butanesulfonate and bis-(4-sulfobutyl) ether disodium of sulfonbutyl-β-cyclodextrin. It can be selected according to the actual situation. Only according to the detection limit and quantitative limit of the two methods, IC-ICD has higher sensitivity.