Fingerprint analysis of placenta polypeptide injection by high performance liquid chromatography

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 °C. 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 injection.