Fingerprint analysis of placenta polypeptide injection by high performance liquid chromatography

作     者：Li Huanga, Xiao-Man Wub, Yu Jib, Yu Wanga,baChina Pharmaceutical University, Nanjing 210009, China bJiangsu Institute for Food and Drug Control, Nanjing 210008, China 

作者机构：China Pharmaceutical University Nanjing 210009 China. Jiangsu Institute for Food and Drug Control Nanjing 210008 China. 

出 版 物：《Journal of Pharmaceutical Analysis》 (药物分析学报（英文版）)

年 卷 期：2012年第2卷第1期

页      面：71-75页

学科分类：1007[医学-药学(可授医学、理学学位)] 10[医学] 

主　　题：Placenta polypeptide injection Fingerprint Similarity analysis High performance liquid chromatography 

摘      要：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 mm) maintained at 30 1C. 0.1% aqueous trifiuoroacetic 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 mL; the fiow 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.