高效液相色谱法测定注射用炎琥宁的含量

Determination of the content of potassium sodium dehydroandroan drographolide succinate for injection by HPLC

目的建立测定注射用炎琥宁的含量的高效液相色谱方法。方法 采用Diamonsil^TM C18柱（4．6mm×200mm，5μm），甲醇-0．05mol·L^-1。磷酸二氢钾溶液[用磷酸调pH值至（2．5±0．05）]（68：32）为流动相，流速：1．0mL·min^-1，检测波长为251nm。结果炎琥宁在0．04312～0．1724mg·mL^-1峰面积与其测定浓度呈良好线性关系（r＝O．9999），平均回收率为99．9％，重复性试验RSD为0．49％（n＝6）。结论本法准确、简便、快速，可用于注射用炎琥宁的含量测定。

Objective To establish an HPLC method to determinate potassium sodium dehydroandrandrographolide succinate. Methods The separation was performed on DiamonsilTM C18 column （4.6 mm×200 mm, 5 μm）. The mobile phase was composed of methanol - 0.05 mol ~ L^-1 potassium dihydrogen phosphate solution -diethylamine [pH adjusted to （2.5±0.05） by H3PO4] （68 ： 32） with the flow rate of 1.0 mL· min^-1 , and the detective wavelength was 251 nm. Results There was a good linearity within 0. 043 12～0. 172 4 mg ·mL^-1 of potassium sodium dehydroandran drographolide succinate （r=0. 999 9）. The average recovery was 99.96%, and the RSD was 0.49% （n=6）.Conclusion This method is accurate, simple and rapid. It is suitable for the quality control of potassium sodium de- hydroandrandrographolide succinate for injection.