【摘要】 目的:建立测定联苯乙酸凝胶的含量和有关物质的方法。方法:采用高效液相色谱法。色谱柱为Kromasil C18,流动相为甲醇-0.1%冰醋酸(65:35),流速为1.0mL·min-1,检测波长为254nm。结果:联苯乙酸检测浓度线性范围为0.3～60μg·mL-1(r=0.9998),低、中、高浓度平均回收率分别为100.3%、101.2%、99.8%,RSD=0.24%(n=9);3批样品主药和有关物质含量均符合限度要求。结论:本方法简便快速、重复性好,可用于控制联苯乙酸凝胶的质量。更多还原

【Abstract】 OBJECTIVE:To determine the contents of Felbinac gel and related substance.METHODS:HPLC method was adopted.The determination was performed on Kromasil C18 with mobile phase consisted of methanol-0.1% glacial acetic acid(65:35) at the flow rate of 1.0 mL·min-1.The detection wavelength was set at 254 nm.RESULTS:The linear range of felbinac was 0.3～60 μg·mL-1(r=0.999 8),and average recoveries were 100.3%,101.2%,99.8% at low,medium and high concentrations(RSD=0.24%,n=9).The contents of main component and impurity in 3 batches of samples were in line with the requirements of limit.CONCLUSION:The method is simple,rapid and reproducible,and it can be used for the quality control of Felbinac gel.更多还原