Method for detecting potential genotoxic impurities in linezolid bulk drug

The invention relates to the technical field of medicine analysis, in particular to a method for detecting potential genotoxic impurities in a linezolid raw material medicine. According to the present invention, the gas chromatography-mass spectrometry combined detection method is adopted to achieve the accurate detection of the potential genotoxic impurities in the linezolid bulk drug, and the detection method has characteristics of strong specificity, high sensitivity, good linear relationship, accurate and reliable quantification, good precision, good repeatability, good durability, and good clinical application prospect. The method can be used for trace detection of potential genotoxic impurities such as 1-chloro-2-propanol, 1, 3-dichloro-2-propanol and 3-chloro-1, 2-propylene glycol in the linezolid bulk drug, and can be used as a basis for quality monitoring of the linezolid bulk drug. 本发明涉及药物分析技术领域，尤其涉及一种利奈唑胺原料药中潜在基因毒性杂质的检测方法。本发明采用气相色谱和质谱联用的检测方法，实现了对利奈唑胺原料药中潜在基因毒性杂质的准确检测，该检测方法专属性强，灵敏度高，线性关系良好，能够准确可靠地定量