【摘要】 目的:建立一种用于分析新的氨基糖苷类抗生素———威替米星的反相离子对高效液相色谱法。方法:直接采用紫外检测器检测威替米星及其有关物质。在AgilentXDBC8柱上威替米星和有关物质达到完全分离,柱温为30°C,流动相为乙腈∶缓冲液(20mmol·L-1庚烷磺酸钠,30mmol·L-1三乙胺,加磷酸调pH至2.5)(25∶75)。结果:方法评价结果显示本法具有良好的线性和重现性。威替米星的最低检测限为0.1μg。结论:本研究建立的方法可以用于测定原料药和注射液中威替米星的含量和有关物质检查。更多还原

【Abstract】 AIM: A simple reversed phase ion-paring high per formance liquid chromatographic method was developed for the analysis of vertilmicin, a new aminoglycoside. METHODS: Direct UV detection was used to determine vertilmicin and its related c om pounds in drug substance and injection products without sample derivatization. Separati on of the vertilmicin from its related compounds was achieved using an Agilent X DB C₈ column at 30 °C and a mobile phase containing （25 %） acetonitrile and a n aqueous buffer (containing (4 g·L^-1) of sodium heptanesulfonate and 4 mL·L^-1 triethylamine) at pH 2.5. RESULTS: The method showed good linearity and repeatability. The li mit of detection for vertilmicin was 0.1μg. CONCLUSION: Reversed phase ion-paring high performance liquid chromatography can be used t o determine the content of vertilmicin and its related compounds in drug substan ce and injection products.更多还原