HPLC法测定双氯芬酸钠肠溶片的含量及含量均匀度

Determination of Diclofenac Sodium Enteric-coated Tablets Content and Content Uniformity by High Performance Liquid Chromatography

目的:建立了高效液相色谱法测定双氯芬酸钠肠溶片中双氯芬酸钠的含量及含量均匀度的方法。方法:色谱柱为KromasilC18(250mm×4.6mm,5μm),流动相为甲醇-水(75:25),用磷酸调节pH至3.50±0.05,检测波长为284nm,流速为1ml?min-1。该方法对双氯芬酸钠的平均回收率为99.40%,RSD为1.24%(n=5)。该法与与标准法比较,没有显著性差别。结果:方法简便,结果准确,专属性强。结论:可用于含量及含量均匀度的测定。

Objective：To establish an HPLC method for the content determination and Uniformity content of diclofenac sodium in diclofenac sodium enteric-coated tablets.Methods：Using KromasilC18（250mm×4.6mm,5μm）as coulmn and methanol-water（adjusted the solution with phosphoric acid to pH=3.50±0.05）（25∶75） as mobile phase at a flow rate of 1mL/min under the wavelength of 284 nm.Results：The average recovery was 99.40 % with the RSD of 1.24%（n = 5）, and there was no obvious difference compared with the standard methods. Conclusion：This method is simple, accurate and specificity, it was suitable for the analysis for this preparation. It can be used for content determination and Uniformity of content of diclofenac sodium in diclofenac sodium enteric-coated tablets.