title: Validation of GC method for quantitative determination of residual 2-(2-chloroethoxy)ethanol (CEE) and N-methyl-2-pyrrolidinone (NMP) in pharmaceutical active substance.
abstract: 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.
authors.affiliation: Pharmaceutical Research Institute, 8 Rydygiera St., 01-793 Warszawa, Poland. e.stolarczyk@ifarm.waw.pl
authors.forename: Elzbieta U
authors.initials: EU
authors.lastname: Stolarczyk
authors.forename: Aleksandra
authors.initials: A
authors.lastname: Groman
authors.forename: Wioleta
authors.initials: W
authors.lastname: Maruszak
mesh_terms: D014150:Antipsychotic Agents / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical; D002849:Chromatography, Gas / Q000592:standards; D003987:Dibenzothiazepines / Q000737:chemistry*; D004340:Drug Contamination; D005019:Ethyl Ethers / Q000032:analysis*; D011760:Pyrrolidinones / Q000032:analysis*; D000069348:Quetiapine Fumarate; D015203:Reproducibility of Results; D012997:Solvents / Q000032:analysis*; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000592:standards
chemical_list: D014150:Antipsychotic Agents; D003987:Dibenzothiazepines; D005019:Ethyl Ethers; D011760:Pyrrolidinones; D012997:Solvents; D000069348:Quetiapine Fumarate; C038678:N-methylpyrrolidone; C523281:2-(2-chloroethoxy)ethanol