新型复方氟苯尼考注射液中氟尼辛葡甲胺含量测定方法研究

Content Determination of Flunixin Meglumine in a Novel Compound Florfenicol Injection by High Performance Liquid Chromatography

为了建立新型复方氟苯尼考注射液中氟尼辛葡甲胺含量的高效液相色谱测定方法，选用Hypersi lODS2（250mm×4．6mm，5μm）色谱柱，流动相为甲醇-0．1％磷酸水（体积比为80：20），检测波长为254nm，柱温30℃，流速1mL／min进行测定。结果显示，氟尼辛葡甲胺在该色谱条件下，系统适应性良好；在27～889gg／mL的质量浓度范围内线性关系良好，回归方程为Y=9596．7X＋32979，R2=0．9999；总平均回收率为（97．16±2．05）％，RSD为2．11％；对5批样品中的氟尼辛葡甲胺进行含量测定，RSD为1．14％。表明该方法可用于新型复方氟苯尼考注射液中氟尼辛葡甲胺含量的测定。

In order to establish the content determination method of flunixin meglumine（FM） in a novel compound florfenicol injection by high performance liquid chromatography（HPLC）, Hypersil ODS2 column（5μm,4.6 min× 250 mm） was used. The HPLC system used a mobile phase composed of methanol-0.1% phosphoric acid water（80 ： 20,V/V） at a flow rate of 1 mL/min,the ultraviolet detector was set at 254 nm with column temperature was 30 ℃. The HPLC system suitability of FM was good. A good linear correlation of FM was observed within the concentration range of 27--889μg/mL（R2 =0. 999 9） ,and the average recovery rate was （97.16±2.05）% with RSD was 2. 11%,the regression equation was Y=9 596.7Xq-32 979. The RSD of FM＇s content in 5 lots of novel compound florfenicol injection was 1.14%. The method was accurate,reliable,improved selective, simple,convenient and quick. The method of FM content determination in this novel compound florfenicol injection by HPLC could be used as the basis of quality control and establishing a quality standard.