RESUMEN
Objective: To establish a high performance liquid chromatography(HPLC)method for the determi- nation of the drug content in thienorphine microspheres. Methods: A COSMOSIL C18 column was used for the HPLC analysis. The mobile phase consisted of acetonitrile -0.02 mol/L phosphate buffer solution(pH=3,containing 0.2% trieth- ylamine)(45:55,V/V)with a flow rate of 1.0 ml/min,and the detection wavelength was 232 nm. The column tempera- ture was 35℃ and the injection volume was 20 μl. Results The quantification limit was 0.10 μg/ml and the detection limit was 0.05 μg/ml. The linear equation for the thienorphine was Y=34.615X,and the calibration curves were linear within the range of 2.14-40.27 μg/m(l r=0.9999). The average recovery for each concentration ranged within 98%-102% (RSD%=1.12%). The drug loading for four batches of microspheres with the same prescription and preparation process was measured by two different Methods:,which produced similar results. Conclusion: The detection method is of good specificity,simplicity,rapidity,sensitivity,reproducibility and high precision,and can be used for the determination of the drug content in thienorphine microspheres.