目的建立盐酸安妥沙星含量及其有关物质检查的高效液相色谱法。方法采用YMC-Pack ODS-AM(4.6mm×150mm,5μm)色谱柱,0.05mol·L^-1磷酸二氢钾(含0.005mol·L^-1己烷磺酸钠,0.007%EDTA,pH2.4±0.1)-乙腈(84∶16)为流动相,检测波长:297nm,流速1mL·min^-1。结果实验表明,安妥沙星在20.0～3000.6mg·L^-1内,峰面积与浓度呈良好的线性关系(r=0.9999),检出限为0.06ng。结论方法准确、简便、专属,能有效控制盐酸安妥沙星的质量色谱法。

OBJECTIVE To establish a HPLC method for the determination of antofloxacin hydrochloride and its related substances. METHODS Antofloxacin was separated and determinated by using a mobile phase consisting of phosphoric buffer solution(0.05 mol·L^-1 potassium dihydrogen phosphate,0.005 mol·L^-1 sodium hexanesulfonate and 0.007%disodium edentate ,pH 2.4±0.1) and acetonitrile (84∶16) at a flow rate of 1 mL·min^-1 on a YMC-Pack ODS-AM (4.6 mm×150 mm,5 μm)column.The detection wavelength was at 297 nm. RESULTS The calibration curves were linear(r=0.999 9) within the range of 20.0～3 000.6 mg·L^-1 for antofloxacin, the detection limit was 0.06 ng(S/N=3).CONCLUSION This method is found to be simple ,selective, accurate and suitable for the quality control of antofloxacin hydrochloride.