RP-HPLC测定醋酸氟轻松的有关物质及其含量  

RP-HPLC determination of fluocinonide and its related substances

作　　者：赵喆[1] 唐素芳[1] 

机构地区：[1]天津市药品检验所,天津300070

出　　处：《药物分析杂志》2009年第12期2137-2140,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立RP-HPLC测定醋酸氟轻松的有关物质和含量。方法:色谱柱:Sepax Sapphire C18(4.6mm×250mm,5μm),流动相:甲醇-乙腈-水(60∶10∶30),流速:1.0mL·min-1,检测波长:240nm,进样量:20μL。结果:醋酸氟轻松有关物质线性范围为0.0693～4.156μg·mL-1(r=0.9992),杂质限度范围为0.05%～3.0%,最低检测限为0.6ng(0.02%);含量测定线性范围为5.05～50.5μg·mL-1(r=0.9999)。结论:本方法准确、简便、快速,可满足醋酸氟轻松的有关物质和含量的测定。Objective：To establish an RP-HPLC method for the determination of the fluocinonide and its related substances.Method：The chromatographic column was Sepax Sapphire C18 （4.6 mm×250 mm,5 μm）,the mobile phase consisted of methanol-acetonitrile-water（60∶10∶30） at flow rate of 1.0 mL·min-1,detection wavelength was 240 nm and the injected volumn was 20 μL.Results：The linear range of the related substances was 0.0693-4.156 μg·mL-1 （r=0.9992）,the detective limit was 0.6 ng（0.02%）,the linear range of the assay was 5.05-50.5 μg·mL-1（r=0.9999）.Conclusion：The method is simple,rapid,specific and accurate.

关 键 词：高效液相色谱法 醋酸氟轻松 有关物质 含量 

分 类 号：R917[医药卫生—药物分析学]