高效液相色谱法测定曲克芦丁注射剂的含量

Quantitative Determination of Troxerutin Injection by HPLC

目的 :建立以高效液相色谱法测定曲克芦丁注射剂含量的方法。方法 :色谱柱为HypersilBDSC18(150mm×5mm ) ,流动相为乙腈 -四氢呋喃 -0 05mol/L磷酸二氢钠溶液 (15∶8∶77 ,pH=4 0) ,柱温为30℃ ,流速为0 8ml/min ,检测波长为254nm。结果 :曲克芦丁标准溶液浓度在20～200μg/ml范围内线性关系良好 (r=0 9998) ,平均回收率为100 7 %;高、中、低3种浓度曲克芦丁样品溶液日内精密度为1 61 %,日间精密度为2 46 %。结论 :该方法简便 ,结果准确 ,适用于曲克芦丁注射剂的质量控制。

OBJECTIVE :To determine the content of Troxerutin in Troxerutin injection by HPLC METHODS :The separation was performed on a Hypersil BDS C18 column The mobile phase was composed of acetontrile-tetrahydrofuran-0.05 mol/Lsodium dihydrogen phosphate(15∶8∶77V/V ) ,adjusted to pH4 0 with phosphoric acid The flow rate was 0 8ml/ min The ultraviolet wavelength was 254nm RESULTS :The calibration curve showed good li nearityinrange of (20～200) μg/ ml(r=0 9998) ;The mean recovery was 100 7 % The within -day RSD was 1 61 %,and inter-day RSD was 2 46 % CONC_ LUSION :The method was simple ,convenient and accurate and can be used for the quality control of Troxerutin injection