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目的:建立了高效液相色谱法测定左氧氟沙星原料及其制剂有关物质。方法:色谱柱:Kromasil~TM C_18 (250 mm×4．6 mm,5μm);柱温:40℃;流动相:0．05 mol·L~(-1)磷酸二氢钾溶液(用氢氧化钠调pH至5．0)·乙腈(87:13);流速:1．0 ml·min~(-1);检测波长:293 nm。结果:左氧氟沙星检测限为1．8 ng,平均回收率为99．4％,RSD为0．4％。结论:本方法快速简便,精密度好,灵敏度高,可作为控制左氧氟沙星原料及其制剂的有关物质。
OBJECTIVE: To establish a HPLC method for the determination of levofloxacin material and its related substances. Methods: Column: Kromasil ~ TM C_18 (250 mm × 4.6 mm, 5 μm); column temperature: 40 ℃; mobile phase: 0.05 mol·L -1 potassium dihydrogen phosphate solution Sodium pH was adjusted to 5.0) · acetonitrile (87:13); flow rate: 1.0 ml · min -1; detection wavelength: 293 nm. Results: The detection limit of levofloxacin was 1.8 ng, the average recovery was 99.4% and the RSD was 0.4%. Conclusion: The method is rapid, simple, accurate and sensitive. It can be used as a control substance for levofloxacin and its preparation.