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目的 建立加校正因子的主成分自身对照法测定加替沙星滴眼液有关物质的含量.方法 采用ZORBAX Eclipse XDB-C18(4.6mm×250mm,5μm)为色谱柱;以1％三乙胺水溶液(用磷酸调节pH值至4.3)-乙腈(87∶13)为流动相,柱温30℃,检测波长254nm,流速1.0mL/min.结果 加替沙星与各杂质分离度良好,各杂质相对校正因子在0.6～1.3范围.结论 以加校正因子的主成分自身对照法测定加替沙星滴眼液有关物质含量的方法简单可行,为加替沙星滴眼液拟定质量标准提供依据.“,”Objective To establish a method of HPLC for the determination of matter in the gatifloxacin ophthalmic,and measuring the relative correction factors of related substances.Methods Formulations were analyzed by using a ZORBAX Eclipse XDB-C 18 column (4.6mm×250mm,5μm) with the 1％ triethylamine aqueous solution (adjusted pH to 4.3 by phosphoric acid)-acetonitrile (87 ∶ 13) for the mobile phase,the column temperature was 30℃,the wavelength was 254nm for the detection,the flowing rate was 1.0mL/min.Results Gatifloxacin was separated well from the impurities,the relative calibration factors of impurities were between 0.6 ～1.3.Conclusion The HPLC method for the determination of matter in the gatifloxacin ophthalmic is accessible and feasible,the main component self-compare with correction factor provides theory basis for the quality standard of gatifloxacin ophthalmic.