A simple and sensitive ion chromatography method for the determination of Ethanolamine in pharmaceutical drug substances

2010 
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, 7mm 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.
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