反相离子对高效液相色谱法测定威替米星及其有关物质的含量  

Determination of vertilmicin and related compounds by reversed phase ion-paring high performance liquid chromatography

作　　者：徐建龙[1] 刘振[1] 段更利[1] 

机构地区：[1]复旦大学药学院药物分析教研室,上海200032

出　　处：《中国新药与临床杂志》2005年第6期465-467,共3页Chinese Journal of New Drugs and Clinical Remedies

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。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 C_8 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.

关 键 词：威替米星 氨基糖苷类 色谱法 高压液相 有关物质 

分 类 号：R927.2[医药卫生—药学] R978.12