【摘要】 目的 :建立盐酸加替沙星滴眼液的制备方法及质量标准。方法 :取盐酸加替沙星 +氯化钠制成0 2 %盐酸加替沙星滴眼液 ,以磷酸盐缓冲液 -乙腈 (81∶19)为流动相 ,采用高效液相色谱法 (C18 柱 )测定盐酸加替沙星的含量。结果 :该方法能很好分离被测组分与其它杂质 ,被测组分浓度线性范围为25～400μg/ml(r=0 9996) ,平均回收率为99 89 % ,RSD=1 55 %。结论 :制备工艺简单 ,质量可控。更多还原

【Abstract】 OBJECTIVE:To establish the preparation process and method of quality control of Gatifloxacin hydrochloride eye-drops.METHODS:Mixing Gatifloxacin hydrochloride with NaCl in water to prepare Gatifloxacin hydrochloride eye-drops.The HPLC system consisted of C 18 column and mobile phase of PBS solution-acetonitrile81∶19.RESULTS:The linear range of Gatifloxacin hydrochloride was25～400μg/ml,r=0.9996.The average recovery rate was99.89%RSD=1.55%. CONCLUSION:The preparation process of Gatifloxacin hydrochloride eye-drops is simple and the method of quality control by HPLC is reliable.更多还原