新型复方氟苯尼考注射液中氟苯尼考HPLC测定方法的建立

Establishment of Content Determination Method of Florfenicol in a Novel Compound Florfenicol Injection by High Performance Liquid Chromatography

为了建立该新型复方氟苯尼考注射液中氟苯尼考的高效液相色谱含量测定方法,采用Hypersil ODS2(5μm,4.6mm×250mm)色谱柱,流动相乙腈-0.5mL/L磷酸水(25∶75,V/V),检测波长224nm,柱温30℃,流速1mL/min为色谱条件。氟苯尼考在该色谱条件下系统适应性好;在5μg/mL^332μg/mL的浓度范围内线性关系良好,回归方程为A=22 390C+17 227,R2=1.000 0;总平均回收率为96.09%±1.79%,RSD为1.87%;5批样品的氟苯尼考含量测定结果的RSD为0.75%。该方法准确可靠、选择性好、简便、快速,可用于新型复方氟苯尼考注射液中氟苯尼考含量的测定,并为该注射液的质量评价奠定基础。

In order to establish the content determination methods of florfenicol （FF）in a novel compound florfeni-col injection by high performance liquid chromatography （HPLC）,Hypersil ODS2 column （5 μm,4.6 mm×250 mm）was used.A mobile phase composed of acetonitrile 0.5 mL/L phosphoric acid water （25∶75,V/V）at a flow rate of 1.0 mL/min.The ultraviolet detector was set at 224 nm and column temperature was 30 ℃.The HPLC system suitability of FF was good.Linear calibration curves were obtained between 5 μg/mL and 332μg/mL with correlative coefficients of 1.000 0,and the regression equation was A=22 390C＋17 227,mean re-covery of FF was 96.09%±1.79%,the relative standard deviation （RSD）was 1.87%.The RSD of FF＇s content in 5 lots of novel compound florfenicol injection was 0.75%.The method showed good accuracy,reliability,im-proved selectivity,and convenience and could be employed to determine the content of FF in this novel compound florfenicol injection for the control of quality and the maker of quality standard.