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反相离子对色谱法分离加替沙星有关物质及其片剂含量测定
http://www.100md.com 2002年5月25日 新药网
     王志群, 黄山, 倪坤仪

    (中国药科大学分析化学教研室,南京 210009)

    [摘要]目的:建立加替沙星有关物质的分离检测及其片剂的含量测定方法。方法:采用反相离子对色谱(RPIC)法,色谱柱为ODS柱,流动相:0.02mol·L-1磷酸二氢钾缓冲液(用磷酸调pH 4.5)-乙腈(82∶18)配制的0.003mol·L-1四丁基溴化铵溶液,流速1.0mL·min-1;检测波长293nm,柱温40℃。结果:建立的色谱方法,有关物质与主药分离良好,加替沙星在4~40μg·mL-1范围内,浓度与峰面积线性关系良好,平均回收率100.2%,RSD=1.8%。结论:本法简便、准确,可用于加替沙星有关物质的检查及片剂含量测定。

    [关键词]加替沙星;有关物质;反相离子对色谱法;含量测定

    [中图分类号]R927.2 [文献标识码]B [文章编号]1003-3734(2001)

    Isolation of related substances and determination of gatifloxacin

    tablets by RPIC

    WANG Zhiqun,HUANG Shan, NI Kunyi

    (Department of Analytical chemistry, China Pharmaceutical University, Nanjing 210009,China)

    [Abstract]Objective: To establish a method for isolation of related substances and determination of gatifloxacin tablets. Methods: Reversed Phase PIC was adopted using ODS column, the mobile phase was 0.003mol·L-1 tetrabutylammonium bromide solution made by 0.02mol·L-1 potassium dihydrogen phosphate buffer solution-acetonitrile (82∶18), and its mobile rate was 1.0mL·min-1. The detective wavelength was 293nm. The temperature of column was 40℃. Resultes: Under the adopled chromatographic condition, the related compounds and Gatifloxacin could be completely separated. In the concentration range of 4~40μg·mL-1, Gatifloxacin had fine linear responses with average recovery of 100.2%, and RSD 1.8%. Conclusions: This method had the advantage of simplicity and accuracy and may be used in quanlity control of gatifloxacin.

    [Key Words]gatifloxacin; related substances; RPIC; quantitative determination

    [作者简介]王志群(1965-),女,讲师,主要从事分析化学及药物分析的教学和科研工作。联系电话:(025)3375891。

    参考文献

    [1]国家药典委员会.中华人民共和国药典[S].2000年版二部.北京:化学工业出版社,2000.附录64.

    [2]杜煜,郭惠元.广谱,高效、低毒的新喹诺酮类抗菌药加替沙星[J].国外医药抗生素分册,2001,22(1):34-39., 百拇医药