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TRIS(77-86-1) solution was used for capillary electrophoresis test

The State Food and Drug Administration promulgated the "capillary electrophoresis analysis of heparin sodium impurities in the supplementary test method" based on the optimization of capillary electrophoresis chromatography conditions, the national evaluation of the test of heparin sodium injection samples were measured.
Methods: Capillary electrophoresis was used to buffer 400 mmol.L-1 TRIS(77-86-1) solution at pH 3.0. The separation voltage was -25 kV. The detection wavelength was 200 nm and the injection pressure was 3.447 kPa. The sample time is 4 s; capillary temperature: 25 °C. 
Results: The separation between heparin peak and polysulfate chondroitin peak was 1.0, and the degree of separation between dermatan sulfate was 2.0, and the results of impurity content were basically the same as those of ion chromatography. Conclusion: The optimized chromatographic conditions increase the separation of heparin from dermatan sulfate and chondroitin sulfate. This method makes qualitative and quantitative quantification of impurities in heparin sodium samples.

 

 

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