Analytical Method Development and Validation for Determination of Residual Solvent in Zopiclone Tablets by Headspace Gas Chromatography

Abstract

A simple and sensitive headspace gas chromatographic method has been developed and
validated for simultaneous determination of isopropyl alcohol and methylene chloride in
zopiclone tablets. The separation was achieved on 75 m long DB-624 fused silica column,
0.53 mm inner diameter and 3 μ film thickness using nitrogen as a carrier gas at 6 ml/min
flow and FID as a detector. The developed gas chromatographic method offers symmetric
peak shape, good resolution and reasonable retention time for all the solvents. The limit of
detection of isopropyl alcohol and methylene chloride was found to be 250 μg/tablet and
90 μg/tablet, respectively.