Original Articles: 2014 Vol: 6 Issue: 7
Development and validation of a headspace gas chromatographic method for the determination of ethyl alcohol in ketorolac tromethamine injection
Abstract
A simple, sensitive, accurate, precise and repeatable HS-GC method was developed for the determination of ethyl
alcohol content in Ketorolac Tromethamine injection USP.Head space Gas chromatography was performed on
Agilent GC with FID detector using Helium as carrier gas at 5.0 ml/min flow with DB-Wax column (30 m x 0.53 mm
ID, film thickness 1μ). The developed method was validated and parameters were found to be within the limits of
USP. The retention time for ethyl alcohol and 1-propanol individually and in spiked standard solution was
determined.The linearity was observed in the concentration range of 25% to 150%.Correlation coefficient was
0.9999 and Y-Intercept was 0.000734. The relative standard deviation of six replicates for intraday was 1.2 % and
Inter day precision was 3.1 % were found to be within the limit.The % recovery for ethanol ranged from 98.1% to
103.6% was found to be within the limit. Hence the proposed method was simple, specific, precise and accurate for
the determination of ethyl alcohol content in Ketorolac Tromethamine injection.