【摘要】 目的 建立高效液相色谱法定量测定磷酸特地唑胺中有关物质的含量。方法 采用加校正因子的主成分外标法，对磷酸特地唑胺中的有关物质进行定量分析，并对该方法进行了方法验证。结果 各组分能够有效分离；磷酸特地唑胺及杂质1～杂质11的定量限均小于0.5 ng，检测限均小于0.2 ng；各组分的浓度与峰面积线性关系良好(r≥0.999)；样品低、中、高三个水平的回收率在90.0%～108.0%内，RSD均<5.0%；6份供试品中检出的杂质个数和含量一致；当色谱条件发生微小变化时，各条件下的检测结果一致。结论 本方法结果专属性强，灵敏度和准确度高，重复性和耐用性良好，可用于测定磷酸特地唑胺中有关物质。更多还原

【Abstract】 Objective To determine the related substances in tedizolid phosphate by high performance liquid chromatography (HPLC).Methods The principal component external standard method and correction factor method were established to determine the related substances in tedizolid phosphate simultaneously.The methods was validated.Results Each component was effectively separated.The quantification limits of tedizolid phosphate and impurities 1 to 11 were all less than 0.5 ng,and the detection limits were all less than 0.2 ng.The concentration of each component had a good linear relationship with the peak area (r≥0.999).The recovery ranged from 90.0% to 108.0%,with RSD all less than 5.0%.The number of impurities in the 6 test samples was consistent with that of the content.When the chromatographic conditions changed slightly,the test results under all conditions remained consistent.Conclusion The method has good specificity,sensitivity,accuracy,repeatability and good durability,and can be used to determine the related substances in tedizolid phosphate.更多还原