高效液相色谱法测定依托度酸的含量

Determination of Etodolac’s content by HPLC

目的：建立高效液相色谱法测定依托度酸的含量。方法：采用C8（250 mm×4.0 mm,5μm）色谱柱;流动相A：6 mL磷酸与1000 mL水混合,流动相B：6 mL磷酸与1000 mL乙腈混合,梯度混合A和B;检测波长：225 nm;柱温：30℃;流速：1.0 mL/min;进样量：5μl。结果：本方法专属性较强,耐用性较好;在0.024744-0.057736 mg/mL范围内线性关系良好;在0.04 mg/mL的80%-125%范围内的总平均回收率为99.93%,RSD为0.5%（n=18）;系统精密度RSD为0.05%-0.23%,重复性RSD为0.21%,中间精密度RSD为0.3%-0.5%。结论：本方法准确、可靠,可用于依托度酸含量的测定。

Object To establish a HPLC method for the determination of Etodolac＇s content.Methods The chromatography column used was C8（250 mm×4.0 mm,5μm）. The mobile phase A was made up of 6ml phosphate and 1000 mL water, The mobile phase B was made up of 6 mL phosphate and 1000ml acetonitrile, Mixing the A and B by the gradient method. The detection wavelength was 225 nm. The column temperature was 30 ℃. The flow rate was 1.0 mL/min. The injection volume was 5p.l.Results Specificity and Durability of the method Complied with requirements.The good linear relationship in a range of 0.024744-0.057736 mg/mL was built. The total average recovery in a range of 80 %-125 % of 0.04 mg/mL was 99.93 %, and the RSD was 0.5 %（n-18）. The RSD of system precisions were 0.05 %-0.23 %. The RSD of the repeatability was 0.21%. The RSD of intermediate precisions were 0.3 %-0.5 %.Conclusions The method is accurate, reliable, and can be used for determination of Etodolac＇s content.