HPLC法测定盐酸环丙沙星乳膏剂和凝胶剂的含量

Determination of the Content of Ciprofloxacin Hydrochloride in Ciprofloxacin Hydrochloride Cream and Gel by HPLC

目的:建立一种理想的盐酸环丙沙星乳膏剂和凝胶剂含量测定方法,统一4个企业的新药转正标准。方法:用甲醇与0.1mol/L 盐酸的混合溶液(1:1)在80℃水浴中加热15分钟萃取软膏,应用高效液相色谱法测定了环丙沙星的含量。色谱条件:Kromasil C_(18)(250mm×4.6mm,5μm)柱;流动相为0.05mol/L 枸橼酸(用三乙胺调节 pH 为3.5)-乙腈(82:18),流速为1ml·min^(-1);紫外检测器,检测波长为277nm。结果:环丙沙星的色谱峰与杂质峰能够较好的分离,4个企业的产品的25%平均加样回收率为96.9%(RSD=0.5%),50%平均加样回收率为98.3%(RSD=1.6%)。结论:方法简便,快速,样品回收率高,重现性好,可用于不同企业生产的环丙沙星软膏的含量测定,能够对药品质量进行控制。

Objective:To establish a method of quantitative analysis of Ciprofloxacin Hydrochloride Cream and Gel by HPLC in order to unify standards of four enterprises.Methods:To determine the Content of Ciprofloxacin of Ciprofloxacin Cream and Gel by HPLC,to extract Ciprofloxacin in cream using a mixture of 0.1mol/L hydrochloric acid-methanol(1:1)as the extrac- tive solvent and to heat up 80℃ in water bath,using a column packed with Kromasil C_(18)(250×4.6mm)and a mixture of 0.05mol/L citric acid solution-acetonitrile(82:18)as the mobile phase,detection wavelength is 277nm.Results:The resolu- tion between peaks of Ciprofloxacin and impurities complies with related requirement,25% of mean application of sample,the mean recoveries of adenosine were 96.9%(RSD 0.5%),50% of mean application of sample,the mean recoveries of adenosine were 98.3%(RSD 1.6%).Conclusion:The method is reliable.