HPLC法测定双氯芬酸钠肠溶片的含量

Determination of Content of Diclofenac Sodium Enteric-coated Tablets by HPLC

目的建立双氯芬酸钠肠溶片含量的HPLC测定方法。方法色谱柱为Agela Technologies Venusil MPC18(4.6 mm×250 mm,5μm);流动相为稀醋酸-甲醇(20∶80);检测波长为276 nm。结果双氯芬酸钠在3～20μg/mL的浓度范围内有良好的线性关系(r=0.999 9,n=5);平均回收率为99.9%,RSD=0.4%(n=9)。结论该方法稳定,准确度、精密度高,重复性好,可用于双氯芬酸钠肠溶片的含量测定。

Objective To establish a method for the content determination of Diclofenac Sodium Enteric-coated tablets by HPLC. Methods The column was Agela Technologies Venusil MPC18 （4.6 mm ×250 ram, 5 μm）, and the mobile phase was diluted acetic acid-Methanol （20： 80）. The detective wavelength was 276 nm. Results The calibration carve of Diclofenac Sodium showed good linearity over the range of 3 - 20 μg/mL （r = 0. 999 9, n = 5）. The average recovery was 99.9% ,RSD =0.4% （n =9）. Conclusion This method is stable, accurate, precise and with good repeatability, it can be used for the content determination of Diclofenac Sodium Enteric-coated tablets.