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
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 Zhiqun,HUANG Shan， NI Kunyi
(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
(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 Zhiqun,HUANG Shan， NI Kunyi
(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