Fingerprint analysis of placenta polypeptide injection by high performance liquid chromatography / 药物分析学报

ABSTRACT

Objective:To develop the representative fingerprint for the quality control of placenta polypeptide injection.Methods:The chromatographic separation was performed using a Phenomenex Gemini C18 column (250 mm × 4.6 mm,5 μm) maintained at 30 ℃.0.1％ aqueous trifluoroacetic acid (Solvent A) and acetonitrile contained 0.1％ TFA (Solvent B) were used as mobile phase with a gradient elution.Detection wavelength was 280 nm with the sample injection volume of 50 μL; the flow rate was 1.0 mL/min.The fingerprints of different samples were investigated by similarity analysis.Results:Nine peaks were identified as the characteristic common peaks.The similarities of the fingerprints of the 10 batches of samples were above 0.992.Conclusion:This method showed high precision and good repeatability,and provided the basis for the improvement of the quality control of placenta polypeptide iniection.