HPLC法检查双氯芬酸钾原料药中的有关物质

Determination of Related Substance in Diclofenac Potassium Raw Material by HPLC

目的：建立检查双氯芬酸钾原料药中有关物质含量的方法。方法：采用高效液相色谱法。色谱柱为UltimateCm流动相为甲醇．4％冰醋酸水溶液（65：35），流速为lml／min，检测波长为254nm。结果：双氯芬酸钾检测质量浓度线性范围为O．2053～51．3350gg／ml（r=O．9999，n---5），检测限为1．54ng。结论：该方法简单、灵敏，可用于双氯芬酸钾原料药中有关物质的检查。

OBJECTIVE： To develop the method for the determination of related substance in diclofenac potassium raw materi- al. METHODS： HPLC was adopted. The determination was performed on Ultimate C18 column with mobile phase consisted of meth- anol-4% acetic acid solution （65：35） at the flow rate of 1 ml/min. The detection wavelength was set at 254 rim. RESULTS： The linear range of diclofenac potassium were 0.205 3-51.335 0 ug/ml （r-0.999 9, n=5）. The lowest detection limit was 1.54 rig. CONCLUSIONS： The method is simple, sensitive and suitable for the determination of related substance in diclofenac potassium raw material.