巴洛沙星片有关物质测定方法的研究

Determination of Related Substances in Balofloxacin Tablets

目的建立RP-HPLC法[1]测定巴洛沙星片的有关物质。方法采用Ecosil C18色谱柱（250 mm×4.6 mm,5μm）,0.05 mol/L磷酸二氢钾溶液（含0.2%三乙胺,用磷酸调节pH值为3.0）为流动相A,乙腈为流动相B,梯度洗脱,流速为1 mL/min,检测波长294 nm。结果采用主成分自身稀释方法测定,方法的专属性强,巴洛沙星在0.195 10~9.752 90μg/mL范围内呈线性,线性方程为A=53.009 7C＋1.508 4,相关系数为：r=0.999 9（n=5）。最低检测限为0.030 pg。结论结果方法准确可靠,重复性好,可用于巴洛沙星片有关物质的测定。

Objective To establish an HPLC method for the determination of related substances in Balofloxacin tablets.Methods The Ecosil Cls was used as the column. The mobile phase consisted of mobile phase A： 0.05 mol/L potassium dihydrogen phosphate solution （containing 0. 2% three triethylamine, pH value was adjusted to 3 with phosphoric acid）, mobile phase B： acetonitrile. Gradient elution chromatography was applied for the determination. The flow rate was 1 mL/min, detection wavelength was at 294 nm. Results Main component self-comparison could be used for testing related substances. The method was sensitive and specific. Balofloxacin had a good linear relationship in the range of 0.195 10-9.752 90 μg/mL, and the calibration curve was A=53.009 7C＋1.508 4, r=0.999 9 （n=5） and the limit of detection was 0.030 pg. Conclusion The method is simple, sensitive and rapid, and it can be used for the determination of related substances in Balofloxacin tablets.