高效液相色谱法同时测定复方氧氟沙星滴耳液中3种组分的含量

Simultaneous HPLC determination of 3 components of compound ofloxacin ear drops

目的 :建立HPLC法同时测定复方氧氟沙星滴耳液中氧氟沙星、替硝唑和地塞米松磷酸钠的含量。方法 :以氯霉素为内标 ,ODS为固定相 ,0 .2 %三乙胺水溶液 (用磷酸调 pH至2 .70 ) 乙腈 (6 8∶32 )为流动相 ,检测波长为 2 40nm。结果 :平均回收率及RSD分别为氧氟沙星 99.5 %,0 .8%;替硝唑 10 1.0 %,1.2 %;地塞米松磷酸钠 98.2 %,1.5 %。结论 :本法简便、快速 ,结果准确 ,适用于该制剂的质量分析检验。

OBJECTIVE To establish a method for determination ofloxacin,tinidacole and dexamethason sodium phosphate in compound of loxacin ear drops.METHODS ODS as stationary phase, 0.2% triethylamine in water(adjusted to pH 2.70 with phosphoric acid)-acetonitrile(68∶32) as mobile phase,chloramphenicol as internal standard,the wavelength of detection was 240nm.RESULTS The average recoveries of ofloxacin,tinidazole and dexamethasone sodium phosphate were 99.5% (RSD= 0.8% ), 101.0% (RSD= 1.2% ) and 98.2% (RSD= 1.5% )respectively.CONCLUSIONS This method is simple,rapid and accurate for quantitative analysis of the preparation.