RESUMEN
Objective: To establish a high performance liquid chromatography(HPLC)method for the determination of the release of TH-302 hepatic artery embolization microspheres in vitro. Methods: The release of TH-302 hepatic artery embolization mi- crospheres in vitro was determined by HPLC. The Venusil ASB C 18 column(4.6 mm×150 mm,5 μm)was used. The mobile phase con- sisted of acetonitrile-water(70:30,V/V)with a flow rate of 1 ml/min,and the detection wavelength was 316 nm. The column tempera- ture was 30℃ and the injection volume was 10 μl. Results: The quantification limit and detection limit were 1.4 and 0.4 μg/ml,re- spectively. The calibration curves were linear within the range of 0.1-10 μg/ml,and the linear equation was Y=10.867X+0.3034(R 2 = 1.0000,n=8). For concentration,the average recovery was within the range of 98.99%-101.77%(n=9)(RSD%=0.07%). The stability results showed that TH-302 was unstable under long-term release conditions,therefore,a linear relationship between the actual degra- dation peak area and the theoretical degradation content of TH-302 was established to calculate the microsphere release accurately. The linear equation was A actual = 0.0523M degredation - 1.4166(R 2 =0.9919). Conclusion: The method could be used for the determination of the release of TH-302 hepatic artery embolization microspheres,which is convenient,fast,sensitive and reproducible,with good pre- cision,specificity and accuracy.