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Determination of 1,2-Dibromoethane in Tramadol Hydrochloride Drug Substances by Head Space Gas Chromatography Linked with Mass Spectrometry
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| Author:
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DUGGIRALA VENKATA, KAPAVARAPU MARUTHI VENKATA NARAYANARAO, PULIPAKA SHYAMALA, RALLABHANDI MURALI KRISHNA, KOMALI SIVA PRASAD
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| Abstract:
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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.
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| Keyword:
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1,2 Dibromoethane, Carcinogen, Tramadol, Gas Chromatography, Detection, Analysis
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2020.12.01.069
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| Download:
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