RP-HPLC法同时测定复方诺氟沙星滴耳液中两组分的含量

目的:建立同时测定复方诺氟沙星滴耳液中诺氟沙星和丙酸倍氯米松含量的RP-HPLC方法。方法:采用Kromasil C18柱(4.6 mm×250 mm,5μm),流动相为甲醇-乙腈-0.025 mol.L-1磷酸溶液(用三乙胺调pH至3.0)-注射用水,梯度洗脱。结果:诺氟沙星和丙酸倍氯米松的线性范围分别为15.0~150.0μg.mL-1(r=0.9996)和2.55~25.5μg.mL-1(r=0.9993),平均回收率为99.4%和99.6%,RSD分别为0.66%和0.89%。结论:本方法准确可靠,为复方诺氟沙星滴耳液的质量控制提供可靠的标准。

Simultaneous Content Determination of Two Constituents in Compound Norfloxacin Ear-Drops with RP-HPLC

Objective To establish a RP-HPLC method that can simultaneously determine the contents of norfloxacin and beclomethasone propionate in compound norfloxacin ear-drops. Methods The RP-HPLC was performed on a Kromasil C18 column （4.6 mm×250 mm,5 μm）, the mobile phase was methanol-acetonitrile-0. 025 mol·L^-1 phosphoric acid solution （ adjusted to pH3.0 with triethylamine） -water for injection, gradient elution. Results The linear ranges of norfloxacin and beclomethasone propionate were 15.0 - 150.0 μg·mL ^-1 （ r = 0. 9996） and 2.55 - 25.5 μg · mL^ -1 （ r = 0.9993 ） , the average recovery rates were 99.4% and 99.6%, with B.SD 0.66% and 0.89%, respectively. Conclusion The method is accurate and reliable for the quality control of compound norfloxacin ear-drops.