HPLC法测定氟比洛芬酯注射液的含量和有关物质

HPLC Simultaneous Determination of Flurbiprofen Axetil and Related Substance from Flurbiprofen Axetil Injection

建立HPLC法同时定量测定氟比洛芬酯注射液中的氟比洛芬酯和氟比洛芬。采用Venusil XBP C18色谱柱(4.6 mm×250 mm,5μm),以V(乙腈)∶V(水)∶V(冰醋酸)=1200∶800∶3为流动相,流速1.0 mL·min^(-1),进样量10μL,柱温40℃,检测波长254 nm。在所选色谱条件下,主药与该有关物质能较好分离,氟比洛芬在0.51~20.22 g·mL^(-1)(r^(2)=0.9999)、氟比洛芬酯在10.36~207.16 g·mL^(-1)(r^(2)=1.0000)范围内线性良好;平均加样回收率(n=9)分别为98.8%和99.3%。该方法简便、快速、灵敏,分离度好,适用于氟比洛芬酯注射液的质量监控。

To establish a quantitative HPLC analytical method for simultaneous determination of flurbiprofen axetil and flurbiprofen in the flurbiprofen axetil injection.The separation was performed on a Venusil XBP C_(18) column(4.6 mm×250 mm,5μm)using an isocratic elution mobile phase system composed of acetonitrile–water–acetic acid(1200∶800∶3)at a flow rate of 1.0 mL·min^(-1),injection volume 10μL,column temperature 40℃and detection wavelengtH_(2)54 nm,respectively.Drug and its related substances were completely separated under selected chromatographic conditions,good linear relationships were observed in the range of flurbiprofen(0.51~20.22 g·mL^(-1);r^(2)=0.9999)and flurbiprofen axetil(10.36~207.16 g·mL^(-1);r^(2)=1.0000).The average recoveries(n=9)of flurbiprofen and flurbiprofen axetil were 98.8%and 99.3%,respectively.This method is simple,rapid,accurate,sensitive and reliable for quality control of the flurbiprofen axetil injection.