RP-HPLC法测定巴洛沙星胶囊的含量及有关物质  

RP-HPLC Determination of Balofloxacin Capsules and Its Related Substances

作　　者：马宁[1] 黄海萍[2] 胡良红[1] 龙彤[1] 郑正春[1] 

机构地区：[1]湖南医药工业研究所,长沙410014 [2]湖南省药品检验所,长沙410001

出　　处：《药物分析杂志》2005年第6期673-675,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:采用反相液相色谱法测定巴洛沙星胶囊含量及有关物质。方法:采用 PICO TAG ^(TM)C_(18)色谱柱(5μm,3.9mm×150mm),以乙腈-水-十二烷基硫酸钠(400∶600∶2.5,用磷酸调节pH为3.0)为流动相;流速1.0mL·min^(-1);检测波长为290nm,柱温:室温;进样量:20μL。结果:在该色谱条件下,巴洛沙星浓度在15-35μg·mL^(-1)范围内具有良好的线性关系,r=0.9999,精密度 RSD 为0.81%(n=6);巴洛沙星胶囊含量测定高、中、低3种浓度的回收率分别为98.3%,100.4%,99.9%;RSD分别为0.56%,0.62%,0.54%。结论:本法简便、快速、准确,专属性好。Objective:An RP-HPLC method was established for the determination of balofloxacin and related sub- stances in its capsules.Method:The separation was performed on a PICO TAG ^(TM)C_(18) column(5μm 3.9 mm×150 mm).The mobile phase was composed of acetonitrile-water-sodium laury sulfate(400:600:2.5),adjusted to pH 3.0 with phosphoric acid.The flow rate was 1.0 mL·min^(-1).The detection was carried out with a UV detector at 290 nm.The chromatography was conducted at room temperature,20 μL were injected.Results:The calibration curves were linears between 15-35μg·mL^(-1)(r=0.9999).The RSD was 0.81%(n=6).The average recov- eries were 98.3%,100.4% and 99.9%(n=3),with RSD of 0.56%,0.62% and 0.54% respectively. Conclusion:The method is proved to be quick,simple and accurate and is suitable for the determination of baloflox- acin and its related substances in its capsules.

关 键 词：巴洛沙星 有关物质 HPLC法 胶囊 反相液相色谱法 十二烷基硫酸钠 RP C18色谱柱 PICO 检测波长 色谱条件 线性关系 含量测定 RSD 流动相 5μg 精密度 回收率 专属性 浓度 

分 类 号：R978.19[医药卫生—药品] R927.2[医药卫生—药学]