Determination of Rocuronium bromide by hydrophilic interaction liquid chromatography (HILIC)

Abstract

A new method involving hydrophilic interaction liquid chromatography (HILIC) has been developed for determination of rocuronium bromide in presents of its main impurities (impurity A and impurity C), which are also its main degradation products, in solution for injection. The influence of the critical chromatographic parameters such as content of acetonitrile in the mobile phase, ionic strength and pH value of the buffer used in the mobile phase were investigated using the Design of experiments approach (DoE). The mechanism of retention of rocuronium bromide on bare silica column was also investigated. Optimal chromatographic conditions were obtained using mixture of acetonitrile and ammonium formate (107.5mM, pH 7.0) in ratio 90:10 as a mobile phase. The validation results have shown that the method is suitable for determination of rocuronium bromid in solution for injection.