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维格列汀基因毒性杂质的气相色谱—质谱分析方法学验证 被引量:3

Validation of GC-MS Method for Determining Genotoxic Impurities in Vildagliptin
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摘要 报道了一种测定维格列汀中的氨基甲酸脂类和对甲苯磺酸脂类基因毒性杂质的气相色谱-质谱联用(GC-MS)方法。采用选择离子监测(SIM)模式,在0.2~2μg/m L浓度范围内,四种目标化合物线性相关系数均大于0.996 0,样品的加标回收率在86.94%~113.11%之间,通过方法精密度实验,方法精密度(RSD%)在5.37%~7.96%之间,精密度良好。该方法能完全满足维格列汀基因毒性杂质氨基甲酸脂类和对甲苯磺酸脂类的检测。 A gas chromatography-mass spectrometry (GC-MS) method was established to determine carbamic acid lipid and p-toluene sulfonic acid lipid in vildagliptin. Selective ion monitoring (SIM) mode was used for four genotoxic imputities in vildagliptin. The linear correlation coefficients were all above 0.996 0 in the range from 0.2 μg/mL to 2 μg/mL. The recoveries of the spiked samples were between 86.94% and 113.11%. The precision of method (RSD%) was from 5.37% to 7.96%. These results showed that the method was accurate, and was able to determine carbarnic acid lipid and p-toluene sulfonic acid lipid in vildagliptin.
出处 《当代化工》 CAS 2017年第2期370-373,共4页 Contemporary Chemical Industry
关键词 气相色谱-质谱联用 氨基甲酸脂类 对甲苯磺酸脂类 选择离子模式 方法精密度 GC-MS Carbamic acid lipid P-toluene sulfonic acid lipid Selected ion mode Precision
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