Special Report: Standard Practice of Liquid Size-Exclusion Chromatography - SEC (GEL Permeation Chromatography - GPC

Abstract

A reversed-phase ion-pair liquid chromatographic method was applied to the analysis of bambuterol hydrochloride chemical reference substance (CRS) and tablets. The purity evaluation of the reference substance was performed with amperometric, UV, diode array and mass spectrometric detection. The total amount of impurities found was less then 0.1%.

For the determination of bambuterol hydrochloride in tablets the method reproducibility was 0.9% and the recovery was in the range 99.8–100.7%. Detection limits for conceivable degradation products were about 1 ng. The suitability of different column packing materials was investigated.