RP-HPLC同时测定诺替可滴耳液中3组分的含量

Determination of Three Components in Nuotike Ear Drops by RP-HPLC

目的:建立诺替可滴耳液中诺氟沙星、替硝唑、氢化可的松的含量测定方法。方法:色谱柱:Kromasil C_(18)柱(250mm×4.6mm,5μm),流动相:甲醇-乙腈-0.025mol·L^(-1)磷酸溶液(用三乙胺调至pH至3.0)-注射用水,梯度洗脱。诺氟沙星,替硝唑,氢化可的松分别为288nm,318nm,245nm,流速:0.8ml·min^(-1),柱温:室温。结果:诺氟沙星、替硝唑、氢化可的松分别在30.0～300μg·ml^(-1)(r=0.999 3)、30.0～300μg·ml^(-1)(r=0.999 7)、5.0～50μg·ml^(-1)(r=0.999 5)浓度范围内,峰面积与浓度的线性关系良好;平均回收率分别为99.5%(RSD=0.61%),99.9%(RSD=0.80%)和99.4%(RSD=0.89%)。结论:所用方法简便快速、结果准确可靠,适用于该复方制剂中3组分的同时测定。

Objective： To establish a method for determination of norfloxacin, tinidazole, hydrocortisone in Nuotike ear drops. Method： The Kromasil C18 column （250mm×4.6mm,5μm） was used, the methanol-acetonitrile- 0.025mol·L^-1 phosphoric acid solution（ adjusted to pH3.0 with triethylamine）-water for injection as mobile phase, gradient elution. Result： The peak areas and concentrations of norfloxacin, tinidazole, hydrocortisone showed the good correlation in following ranges： 30. 0-300μg·ml^-1（ r = 0. 999 3 ）, 30.0 - 300μg·ml^-1（ r = 0.999 7 ） ,5.0 - 50μg·ml^-1 （ r = 0. 999 5 ） respectively ; The average recoveries were 99.5 % （ RSD = 0.61% ）, 99.9% （ RSD = 0.80% ） and 99.4% （ RSD = 0.89% ）, respectively. Conclusion： The method is simple, sensitive, accurate and suitable for the determination of three components in Nuotike ear drops.