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.