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- Title
Determination of 1,2-Dibromoethane in Tramadol Hydrochloride Drug Substances by Head Space Gas Chromatography Linked with Mass Spectrometry.
- Authors
VARDHANI DEVI, DUGGIRALA PARVATHA VENKATA; NARAYANARAO, KAPAVARAPU MARUTHI VENKATA; SHYAMALA, PULIPAKA; KRISHNA, RALLABHANDI MURALI; PRASAD, KOMALI SIVA
- Abstract
1,2 Dibromoethane is a known carcinogenic impurity that needs to be controlled in pharmaceutical processes. This study describes a sensitive Gas chromatography-Mass spectrometric method (GC-MS) for detection and estimation of 1,2 dibromoethane in tramadol HCl drug substances. The proposed method detected up to 0.29 ppm of 1,2 dibromoethane with signal to noise ratio >3 and quantified up to 0.96 ppm of 1,2 dibromoethane with signal to noise ratio >10. Response was linear in concentration range 0.96 - 5.6775 ppm with correlation coefficient value of 0.9993. Recovery of 1,2 dibromoethane from tramadol HCl samples spiked at three concentrations were from 101.4 to 108.7%. This validated procedure can be used as a standard system for the identification and quantification of 1,2 dibromoethane for the control of pharmaceutical process.
- Subjects
ETHYLENE dibromide; TRAMADOL; CHROMATOGRAPHIC analysis; MASS spectrometry; CARCINOGENS
- Publication
International Journal of Pharmaceutical Research (09752366), 2020, Vol 12, Issue 1, p949
- ISSN
0975-2366
- Publication type
Article
- DOI
10.31838/ijpr/2020.12.01.069