超高效液相色谱-四级杆-静电场轨道阱高分辨液质联用解析泰地罗新注射液中的有关物质

目的 本方法建立了超高效液相色谱-四级杆-静电场轨道阱高分辨质谱联用(UHPLC-Q Exactive)分析注射用泰地罗新中的有关物质。方法 采用(Zorbax SB-C18, 100mm×3.0mm, 1.8μm) 色谱柱，以0.1%三氟乙酸溶液(A)-0.1%三氟乙酸乙腈溶液(B)为流动相，0.3mL/min线性梯度洗脱分离；采用全扫描及自动触发二级质谱扫描的功能测定。采集有关物质的质谱母离子及子离子谱，并进行解析，推测有关物质的结构。结果 在所建立的条件下，泰地罗新及其有关物质之间分离良好，检测出12个有关物质，并对其进行结构解析。结论 建立的Q Exactive四级杆-静电场轨道阱高分辨质谱法能有效地分离分析泰地罗新及其有关物质，为注射用泰地罗新的质量控制和工艺优化提供了参考。

Analysis of the related substances in tildipirosin for injection by ultra high performance liquid chromatography coupled with hybrid quadrupole orbitrap mass spectrometry#br#

Objective An ultra high performance liquid chromatography coupled with hybrid quadrupole orbitrap mass spectrometry method (UHPLC-Q Exactive) was developed for the analysis of the related substances in tildipirosin for injection. Methods The UHPLC separation was carried out on a Zorbax SB-C18 (100mm×3.0mm, 1.8μm) by the gradient elution with a mobile phase consisting of 0.1% trifluoroacetic acid aqueous solution (A) and 0.1% trifluoroacetic acid acetonitrile solution (B) at a flow rate of 0.3mL/min. The rapid screening was carried out by Full MS/dd-MS2. The analysis of the related substances were performed with the parent ions and the fragments ions by data dependent scan mode. Results Good resolution of tildipirosin and the main related substances were achieved. Twelve related substances in tildipirosin for injection were separated and detected. Conclusion The established method is effective for the separation and identification of the related substances in tildipirosin for injection and the results are useful for its quality control and process