摘要
目的建立反相高效液相色谱法测定普卢利沙星的含量并检测有关物质。方法色谱柱为Diamonsil C18柱（250 mm×4.6 mm,5μm）,以1 mol.L-1戊烷磺酸钠溶液-水-乙腈=2∶85∶113（磷酸调pH值为3.0）为流动相,流速为1.0 mL.min-1,检测波长为275 nm,柱温为室温。结果在该色谱条件下,普卢利沙星、中间体（Ⅰ、Ⅱ、Ⅲ、Ⅳ、Ⅴ、Ⅵ、Ⅶ）、化合物Ⅷ均能完全分离,普卢利沙星在浓度8.6~77.4μg.mL-1与峰面积线性关系良好（r=0.999 98）,平均回收率为99.6%,RSD为0.5%,最低检出量均≤30 ng。结论本法简便、快速、准确、专属性好,可用于普卢利沙星的质量控制。
Objective To establish an RP-HPLC method to determine the relevant substance and the content of prulifloxacin.Methods Diamonsil C18 column（250 mm×4.6 mm,5 μm） was used,and the mobile phase consisted of 1 mol·L-1 sodium pentanesulfonate solution-water-acetonitrile（2∶85∶113;pH was adjusted to 3.0 by phosphoric acid）.The flow rate was 1.0 mL·min-1,the UV detective wavelength was 275 nm,and the column temperature was room temperature.Results Prulifloxacin and its relevant substances were completely separated.The linear range was 8.6-77.4 μg·mL-1（r=0.999 98）,the average recovery was 99.6%,RSD=0.5%,and the limit of detection was less than 30 ng.Conclusion The method is simple,rapid,accurate and reproducible.It can be used to control the quality of prulifloxacin.
出处
《中南药学》
CAS
2011年第1期28-32,共5页
Central South Pharmacy
