HPLC测定利奈唑胺注射液中利奈唑胺的含量及其有关物质

Determination of Linezolid Content and Related Substances in Linezolid Injection by HPLC

目的建立高效液相色谱法测定利奈唑胺注射液中利奈唑胺含量及其有关物质的方法。方法色谱柱为EclipseXDB-C18,流动相为甲醇-水(45∶55),流速1.0 mL.min 1,检测波长254 nm,柱温25℃。结果利奈唑胺浓度在0.5～250mg.L 1内线性关系良好(r=0.999 8),最低检测量1 ng,低、中、高3种浓度的平均回收率分别为99.3%,100.9%,100.5%。结论该方法简便、灵敏、准确,专属性强,适合于利奈唑胺注射液中利奈唑胺含量及其有关物质的测定。

OBJECTIVE To establish an HPLC method for the determination of linezolid and related substances in linezolid injection. METHODS The analytical column was Eclipse XDB-C18, the mobile phase was methanol-water（45 ： 55）, the flow rate was 1.0 mL·min-1. The detection wavelength was 254 nm, and the column temperature was 25℃. RESULTS The linear range of calibration curve was 0.5-250 mg·L-1（r=0.999 8）, and the limit of detection was 1 ng. The average recovery of three concentrations were 99.3%, 100.9%, 100.5%, respectively. CONCLUSION The method is simple, sensitive andaccurate, and can control the quality of the preparation effectively.