HPLC对盐酸安妥沙星含量及有关物质测定的研究

Determination of Antofloxacin Hydrochloride and Its Related Substances by HPLC

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 p,m） 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^-lfor 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.