Determination of Residual Organic Solvents in Meropenem by Headspace Gas Chromatography / 中国药房

ABSTRACT

OBJECTIVE:To develop a headspace GC method for determination of residual organic solvents invovling methanol,alcohol,acetone,acetonitrile,dichloromethane and n-butanol in meropenem.METHODS:The residual organic solvents were separated on DB-624 capillary column using temperature programming.FID was used as detector with a temperature of 250 ℃ with nitrogen as carrier gas and water as solvent.The inlet temperature was 200 ℃.RESULTS:The linear range were 12～600 ?g?mL-1 (r=0.999 8) for methanol,20～1 000 ?g?mL-1 (r=0.999 9) for alcohol,20～1 000 ?g?mL-1 (r=0.999 9) for acetone,1.64～82 ?g?mL-1 (r=0.999 8) for acetonitrile,2.4～120 ?g?mL-1 (r=0.999 6) for dichloromethane and 20～1 000 ?g?mL-1 (r=0.999 9) for n-butanol with RSD of 1.0%,2.2%,0.9%,2.2%,1.6%,1.1%,respectively.The average recoveries were ranged from 98.8% to 99.6%.The LOD were about 0.06～0.43 ng.The residual levels of six organic solvents in 3 batches samples were all up to the standard stated in Chinese Pharmacopeia (2005 edition).CONCLUSION:The method is simple,accurate,sensitive and reproducible for determination of residual organic solvents in meropenem.