Validation of GC method for quantitative determination of residual 2-(2-chloroethoxy)ethanol (CEE) and N-methyl-2-pyrrolidinone (NMP) in pharmaceutical active substance

The gas chromatography method with direct injection for quantitative determination of residual nonvolatile solvents such as 2-(2-chloroethoxy)ethanol (CEE) and N-methyl-2-pyrrolidinone (NMP) in quetiapine--the pharmaceutical active substance has been validated. Validation was performed according to...

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Veröffentlicht in:	Acta Poloniae pharmaceutica 2011-03, Vol.68 (2), p.161
Hauptverfasser:	Stolarczyk, Elzbieta U, Groman, Aleksandra, Maruszak, Wioleta
Format:	Artikel
Sprache:	eng
Schlagworte:	Antipsychotic Agents - chemistry Chemistry, Pharmaceutical Chromatography, Gas - standards Dibenzothiazepines - chemistry Drug Contamination Ethyl Ethers - analysis Pyrrolidinones - analysis Quetiapine Fumarate Reproducibility of Results Solvents - analysis Technology, Pharmaceutical - methods Technology, Pharmaceutical - standards
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Zusammenfassung:	The gas chromatography method with direct injection for quantitative determination of residual nonvolatile solvents such as 2-(2-chloroethoxy)ethanol (CEE) and N-methyl-2-pyrrolidinone (NMP) in quetiapine--the pharmaceutical active substance has been validated. Validation was performed according to the requirement of ICH validation guidelines Q2A and Q2B. Specificity, precision, accuracy, linearity, limits of detection and quantitation and robustness were determined and excellent results were obtained.
ISSN:	0001-6837