Abstract��
OBJECTIVE To apply the heparin sodium molecular weight reference standard calibrated in the first study period to GPC method and assesse the GPC method. METHODS GPC methods were used. The columns were G4000SWXL(7.8 mm��30 cm)-TSK G3000SWXL(7.8 mm��30 cm) in series maintained at 30 ��. The mobile phase was 0.1 mmol��L-1 ammonium acetate solution containing 0.02% NaN3 eluted at a flow rate of 0.6 mL��min-1. The samples were injected after a column equilibration period of 2 h and the injection volume was 20 ��L. The analysis was performed by RI detector. RESULTS The analysis result passed the system suitability test, with measured values in the middle of the report. The precision and accuracy were good. The reference standard and GPC method calibrated in this study have already been recorded in USP37. CONCLUSION The methods and ideas we used are suitable for the calibration of other polysaccharides.
SONG Yu-Juan,
FAN Hui-Hong-*
.The Second International Collaborative Study on Molecular Weight of Heparin Sodium Reference Standard[J] Chinese Pharmaceutical Journal, 2014,V49(23): 2124-2127
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[1]
GAO N G,CHENG X L,YANG J,et al. Progress in heparin structure and function . Prog Biotechnol(���﹤�̽�չ),1999,19(3): 4-9.[2] SONG Y J, FAN H H. The first international collaborative study on molecular weight of heparin sodium reference standard . Chin Pharm J(�й�ҩѧ��־),2014,49(22):2023-2026.[3] USP37/NF32 .2014:2793.
2014, Vol. 49 
