RP-HPLC法测定醋酸可的松滴眼液主药及有关物质的含量  

Determination of the Contents of Main Component and Its Related Substances in Cortisone Acetate Eye Drops by RP-HPLC

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：《中国药房》2012年第17期1616-1618,共3页China Pharmacy

摘　　要：目的:建立测定醋酸可的松滴眼液主药及有关物质含量的方法。方法:采用反相高效液相色谱法。色谱柱:Agilent C18,流动相:乙腈-水(36∶64),流速:1.1 mL.min-1,检测波长:254 nm,进样量:10μL。结果:醋酸可的松的有关物质检测浓度线性范围为1.0～20.0μg.mL-(1r=1.000 0),相应杂质限度范围为0.1%～2.0%,最低检测限为5 ng(0.05%);主药含量测定的检测浓度线性范围为41.9～168μg.mL-(1r=1.000 0),平均回收率为100.6%(RSD=0.7%)。结论:本方法准确、简便、快速,可满足醋酸可的松主药和有关物质含量测定的要求。OBJECTIVE：To establish a method for the content determination of main component and its related substances in Cortisone acetate eye drops.METHODS：RP-HPLC method was adopted.The chromatographic column was Agilent C18 column with mobile phase consisted of acetonitrile-water（36∶64）at the flow rate of 1.1 mL.min-1.The detection wavelength was set at 254 nm and the injection volume was 10 μL.RESULTS：The linear range for related substances was 1.0～20.0 μg.mL-1（r=1.000 0） and the limit of related impurity was 0.1%～2.0%;the detective limit was 5 ng（0.05%）.The linear range of main component was 41.9～168 μg.mL-1（r=1.000 0）with an average recovery of 100.6%（RSD=0.7%）.CONCLUSION：The method is accurate,simple and rapid,and it is suitable for the content determination of main components and related substance in Cortisone acetate eye drops.

关 键 词：醋酸可的松滴眼液 有关物质 反相高效液相色谱法 含量测定 

分 类 号：R927.2[医药卫生—药学] R977.11