HPLC-DAD法检测马波沙星片中马波沙星氧化物的研究

Content Determination of Marbofloxacin oxide in Marbofloxacin Tablets by HPLC-DAD

关键词:  马波沙星  氧化物  高效液相色谱法

Key words:  Marbofloxacin  oxide  HPLC-DAD

摘要:

建立并验证了高效液相色谱法测定马波沙星片中马波沙星氧化物含量的方法。试验采用十八烷基硅烷键合硅胶色谱柱（4.6 mm×250 mm，5 μm），以辛烷磺酸钠磷酸盐缓冲液-甲醇-四氢呋喃（65∶32∶3）为流动相，流速1.0 mL/min，柱温30 ℃，检测波长为210～400 nm。试验结果表明：马波沙星氧化物在0.5～100 μg/mL范国内线性良好，R2=0.9997，平均回收率为95.9%（n=9），RSD≤1.5%。方法检测限为0.2 μg/mL，专属性好，可用于马波沙星片的质量控制。

Abstract:

The method for content determination of Marbofloxacin oxide in Marbofloxacin tablets by HPLC-DAD was developed and validated. The test was performed on a C18 column(4.6 mm×250 mm, 5 um) mixed with 32 volumes of methanol and 3 volumes Tetrahydrofuran with 65 volumes of Sodium octane sulfonate phosphate buffer as the mobile phase. The flow rate was 1.0 mL/min., the column temperature was 30℃, and the determination wave length was 210～400 nm. It is shown that the good linear relationship was accepted in the range of 0.5~100 μg/mL.(r2= 0.9997),and the average recovery was 95.9%(n=9) with RSD less than or equal to 1.5%.This method has the good specificity, as the limit of detection was 0.2 μg/mL. As the result, this method was suitable to control the quality of Marbofloxacin Tablets.