Original Articles
C. Hazarathaiah Yadav and D. M
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.