用RP-HPLC法测定巴洛沙星中间体含量的方法学研究

Assaying of balofloxacin carboxylic acester by RP HPLC

目的 测定巴洛沙星合成中的主要中间体羧酸乙酯在巴洛沙星中的含量。方法 反相高效液相色谱法(RP HPLC)。结果 样品在 0 .3 0～ 5 .96μg·ml-1范围内线性关系良好 ,中间体的平均回收率为 96.2 % ,相对标准偏差(RSD)为 1.85 %。结论 RP HPLC法测定准确 ,重现性良好 ,可用于巴洛沙星的质量控制。

Objective To determine the content of balofloxacin carboxylic acester during the synthesize of balofloxacin.Methods The content of balofloxacn carboxylic acester was assayed by reverse phase high press liquid chromatography (RP?HPLC).Results There was a good linear relationship within the range of 0.30～5.96?μg·ml( r =0.99997).The average recovery and relative standard deviation of the method were 96.2% and 1.85% respectively. Conclusion The method is accurate,precise and reproducible for the quality control of balofloxacin.