高效液相色谱法测定吲哚美辛缓释微球的含量

HPLC Determination of Indomethacin Content in Indomethacin Microspheres

建立吲哚美辛缓释微球中吲哚美辛含量的高效液相色谱方法。采用Zorbax Eclipse XDB-C18色谱柱(4.6 mm×150 mm,5μm),以pH 3.0的0.1 mol/L冰醋酸溶液-乙腈(20∶80)为流动相,流速为1.0 mL/min,柱温为30℃,检测波长为320 nm,进样量20μL,用外标法测得。吲哚美辛在2.0～80.0μg/mL范围内线性关系良好(r=0.999 9),平均回收率为98.70%,RSD为1.50%。本方法灵敏度高,操作简单可靠。

Indomethacin microspheres were prepared by O/W solvent evaporation using PLGA and Eudragit RS 100,the mean diameters were 2 588.3±1 202.2 nm.A HPLC method for determiny indomethacin content in indomethacin microspheres was established.ZORBAX Eclipse XDB-C18 column（4.6 mm×150 mm,5 μm） was used with mobile phase consisting of 0.1mol/L glacial acetic acid（adjusted pH valne to 3.0）-acetonitrile（20∶80） and with a total flow rate of 1.0 mL/min.The column temperature was 30 °C.The UV detection wavelength was 320 nm,with injection amount 20 μL.The indomethacin curve was linear in the rangs of 2.0~80.0 μg/mL and the regression equation was Area=11.642×Amt＋0.762,r=0.999 9.The average recovery of indomethacin was 98.70%,and the RSD was 1.50%.The method appeared to be highly sensitive,accurate and simple.It can be used to determine indomethacin content in indomethacin microspheres.