Application of content determination of principal agent in recombinant human granulocyte macrophage colony stimulating factor freeze-dried powder injection by HPLC
Abstract：ObjectiveTo establish the method of the main active ingredients in recombinant human granulocyte macrophage colony stimulating factor freeze-dried powder injection(rhGM-CSF)by HPLC.MethodsThe chromatographic condition of HPLC was chromatographic column(TSK gel G3000SW,300.0 mm×7.5 mm,5 μm),Mobile phase was 0.1 mol/L phosphate buffer,Flow rate was 1 ml/min,automatic sampling was 20-40 μl and detection wavelength was 280 nm.Analyzing the ingredients of rhGM-CSF freeze dried powder injection,reproducibility and linear relationship between different sample volume and peak area of each component under this chromatographic condition were studied in this experiment.ResultsThe main components of rhGM-CSF freeze dried powder injection were rhGM-CSF protein and human albumin.The rhGM-CSF protein sample volume and peak area were good linear(R2＞0.99)and the percentage content of RSD values was less than 3%.ConclusionThis method could be used to detect the active component content of the rhGM-CSF lyophilized powder for injection protein with 10-20 μg scope.
京公网安备 11010502046607号