高效液相色谱法测定巴罗沙星药物含量的研究

Determination of balofloxacin by HPLC

目的探讨应用高效液相色谱(HPLC)法测定巴罗沙星药物含量的方法。方法采用HPLC法,设定色谱柱为Agilent ZORBAX SB-C18(4.6×150 mm,5μm),流动相为乙腈-1.25%三乙胺溶液(用磷酸调pH至4.5)(22:78),检测波长为254mm。进行精密度试验和回收率试验并做线性关系分析。结果线性范围:巴罗沙星在0.0247～0.987 mg/ml范围内,浓度与峰面积呈良好线性关系(r=1.0000);重复性试验:西多福韦RSD为0.20%;巴罗沙星的平均回收率为101.23%,RSD为1.46%(n=9)。结论HPLC法结果准确,操作简便,可作为巴罗沙星含量的测定方法。

Objective To establish an HPLC method for determination of the content of balofloxacin. Methods Chromato- graphic system was used involving a SB - C18 column （4.6 × 150 mm,5 μm）. The mobile phase consisted of 1.25% triethylamine so- lution （adding H3PO4 to pH4.5） and acetonitrile （78：22）. The UV detector wavelength was set at 254 nm. Results The linear range for balofloxacin was 0. 0247 - O. 987 mg/ml, r = 1. 0000. The precision for balofloxacin RSD was O. 20% . The average recovery rate was 101.23 % , RSD 1.46 %. Conclusion The method is simple , rapid , accurate and suitable for quantitation analysis of the balo- floxacin.