氟比洛芬干混悬剂中氟比洛芬的含量测定

Content Determination of Flurbiprofen Dry Suspension by HPLC

目的建立高效液相色谱(HPLC)法测定氟比洛芬干混悬剂中氟比洛芬的含量。方法色谱柱为HypersilC18柱(250mm×4.6mm,5μm),流动相为乙腈-0.02mol/L磷酸二氢钾缓冲液(54∶46,三乙胺调pH值至6.0),检测波长为254nm。结果氟比洛芬质量浓度线性范围是2.0～64.0μg/mL(r=0.9999),日内精密度RSD≤0.79%,日间精密度RSD≤1.04%,平均回收率分别为99.38%,100.05%,99.78%。结论HPLC法专属性强,结果准确,适用于氟比洛芬干混悬剂的含量测定。

Objective To establish a HPLC method for determining the content of flurbiprofen in flurbiprofen dry suspension. Methods The Hypersil C18 column （250 mm×4. 6 mm,5μm） was used with the mobile phase of acetonitrile： 0.02 mol/L KH2PO4 （54： 46,adjusting pH 6.0 with triethylamine） and the detection wavelength was 254 nm. Results The method had a good linear relationship in the rang of 2. 0 - 64. 0μg/mL （ r = 0. 999 9）. The precision of intra - day and inter - day RSD was ≤0. 79% and ≤1.04% , respectively. The average recovery rate of low,medium and high concentration of flurbiprofen was 99.38%, 100. 05% and 99. 78%,respectively. Conclusion The method is selective and accurate for the content determination of flurbiprofen in flurbiprofen dry suspension.