Feng Xiao-Zhen, Han Guo-Cheng, Qin Jianhe, Yin Shi-Min, Chen Zhencheng
School of Life and Environmental Sciences, Guilin University of Electronic Technology, Jinji Road No.1, Guilin 541004, P. R. China.
School of Life and Environmental Sciences, Guilin University of Electronic Technology, Jinji Road No.1, Guilin 541004, P. R. China
J Chromatogr Sci. 2016 Apr;54(4):487-91. doi: 10.1093/chromsci/bmv175. Epub 2015 Dec 10.
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.
建立了一种顶空气相色谱法用于测定利奈唑胺活性物质中的残留溶剂。这些溶剂包括石油醚（60 - 90°C）、丙酮、四氢呋喃、乙酸乙酯、甲醇、二氯甲烷（DCM）和吡啶。该方法显示，除石油醚（0.9980）外，对所测试的溶剂具有线性测定相关系数（r）大于0.9995的检测可能性。检测限在0.12μg/mL（石油醚）至3.56μg/mL（二氯甲烷）之间，定量限在0.41μg/mL（石油醚）至11.86μg/mL（二氯甲烷）之间。该方法对所有七种相关溶剂均具有良好的准确度（回收率在92.8%至102.5%之间）以及批内和批间测定的精密度（相对标准偏差在0.4%至1.3%之间），并成功应用于三批利奈唑胺的质量控制。
