A simple and sensitive ion chromatography method for the determination of Ethanolamine in pharmaceutical drug substances
By S. John Prasanna , K. S. R. Pavan Kumar , K. Mukkanti , Vundavilli Jagadeesh Kumar and Hemant Kumar Sharma
ABSTRACT
A simple and sensitive ion chromatography method was developed and optimized for the
determination of content of ethanolamine at very low levels in pantoprazole sodium, amlodipine
besylate and carvedilol pharmaceutical drug substances. The mobile phase was consisted of
4mmole of tartaric acid and 1mmole of dipicolinic acid in water using METROSEP C 2 250
(Metrohm, 250mm x 4.0mm, 7µm particle size) column at ambient temperature. The retention
time of ethanolamine was about 10 min and the total acquisition time was 25 min. The optimized
method was validated to prove its performance characteristics by demonstrating selectivity,
sensitivity (limit of detection and quantification), linearity, precision and accuracy. The
established limit of detection and limit of quantification of ethanolamine was found to be
67ng/ml and 204ng/ml respectively.
Keywords: Ion chromatography, ethanolamine, pantoprazole sodium, carvedilol, amlodipine
besylate, validation.
