HPLC法测定硝酸异康唑软膏中的硝酸异康唑的含量及有关物质

Study on the Content of Isoconazole Nitrate and Determination of Its Related Substances In Isoconazole Nitrate Cream by HPLC

目的:建立高效液相色谱法,测定硝酸异康唑软膏中的硝酸异康唑的含量及有关物质。方法:用ZORBAXExtendC18(250mm×4.6mm,5μm)色谱柱,2%醋酸铵溶液-甲醇-乙腈(270∶375∶355)为流动相,检测波K为235nm。结果:硝酸异康唑与硝酸益康唑的分离度大于5.0及检出灵敏度完全达到要求,最小检出量为0.02μg。浓度在40～250μg.mL-1内线性关系良好(r=1.0000,n=6)。平均回收率为101.1%,RSD为1.1%。结论:本方法准确、简便、快速,能有效控制硝酸异康唑软膏的质量。

Objective： To establish an HPLC method for the Content of Isoconazole Nitrate and the determination of its related substances in Isoconazole Nitrate Cream . Method： ZORBAX Extend C18 column was used with 2% ammonium acetatemethanol-acetonitrile（270 ： 375 ： 355）as the mobile phase. The detection wavelength was at 235nm. Results： The resolution was acceptable. The detection was 0.02μg. The linear range was 40- 250μg · mL^-1 （r =1. 0000,n ： 6）. The average recovery was 101. % （RSD= 1.1 %）. Conclusions ：This method is accurate ,simple and sensitive. It can be used to control the quality of Isoconazole Nitrate Cream.