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

Isolation of related substances and determination of gatifloxacin tablets by RPIC

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 ,流动相为 0 .0 2mol·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 .0 0 3mol·L-1四丁基溴化铵溶液 ,流速为 1.0mL·min-1;检测波长为 2 93nm ,柱温为 4 0℃。结果 :建立的色谱方法使有关物质与主药分离良好 ,加替沙星在 4～ 4 0 μg·mL-1范围内 ,浓度与峰面积线性关系良好 ,平均回收率 10 0 .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。

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 adopted 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 of 1.8%.Conclusion:This method is simple and accurate and may be used in quality control of gatifloxacin.