title: Determination of Residual Solvents in Linezolid by Static Headspace GC.
abstract: A headspace gas chromatographic method was developed for the determination of residual solvents in linezolid active substances. The solvents include petroleum ether (60-90°C), acetone, tetrahydrofuran, ethyl acetate, methanol, dichloromethane (DCM) and pyridine. The method showed the possibility to detect the tested solvents with a linear determination correlation coefficient (r) greater than 0.9995 except for petroleum ether (0.9980). The limits of detection ranged between 0.12 μg/mL (petroleum ether) and 3.56 μg/mL (DCM), and the limits of quantity ranged between 0.41 μg/mL (petroleum ether) and 11.86 μg/mL (DCM). The method achieved good accuracy (recoveries ranging from 92.8 to 102.5%) and precision for both run-to-run and day-to-day assay (relative standard deviation ranging from 0.4 to 1.3%) for all seven solvents concerned, which were applied in the quality control of three batches of linezolid successfully.
authors.affiliation: School of Life and Environmental Sciences, Guilin University of Electronic Technology, Jinji Road No.1, Guilin 541004, P. R. China.
authors.forename: Xiao-Zhen
authors.initials: XZ
authors.lastname: Feng
authors.affiliation: School of Life and Environmental Sciences, Guilin University of Electronic Technology, Jinji Road No.1, Guilin 541004, P. R. China hangc1981@163.com.
authors.forename: Guo-Cheng
authors.initials: GC
authors.lastname: Han
authors.affiliation: Guilin Pharmaceutical Company Limited, Guilin 541004, P. R. China.
authors.forename: Jianhe
authors.initials: J
authors.lastname: Qin
authors.affiliation: School of Life and Environmental Sciences, Guilin University of Electronic Technology, Jinji Road No.1, Guilin 541004, P. R. China.
authors.forename: Shi-Min
authors.initials: SM
authors.lastname: Yin
authors.affiliation: School of Life and Environmental Sciences, Guilin University of Electronic Technology, Jinji Road No.1, Guilin 541004, P. R. China.
authors.forename: Zhencheng
authors.initials: Z
authors.lastname: Chen
mesh_terms: D002849:Chromatography, Gas / Q000379:methods*; D057230:Limit of Detection; D000069349:Linezolid / Q000737:chemistry*; D015203:Reproducibility of Results; D012997:Solvents / Q000032:analysis*
chemical_list: D012997:Solvents; D000069349:Linezolid