ANALYTICAL METHOD VALIDATION FOR DETERMINATION OF RESIDUAL TRIETHYLAMINE CONTENT IN ERTAPENEM SODIUM BY HEAD SPACE GAS CHROMATOGRAPHY
Keywords:
Triethylamine, Ertapenem Sodium, Validation, Gas ChromatographyAbstract
The analysis of residual organic solvent Triethylamine in Ertapenem Sodium, an active pharmaceutical ingredient was investigated. Ertapenem is used to treat certain serious infections, including pneumonia and urinary tract, skin, diabetic foot, gynecological, pelvic, and abdominal (stomach area) infections, that are caused by bacteria. The Headspace gas chromatography method described in this investigation utilized HP-5, 30 meter x 0.53 mm with 5.0 μm, FID detector. The injector temperature was set at 220ºC. Nitrogen was used as a carrier gas. The method was validated to be specific, linear, precise, sensitive, rugged and showed excellent recovery.




