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HPLC
1
*
( 100050)
HPLC Waters Alliance
Waters 2414 Zorbax Carbohydrate Analysis
ACN:H2O=70:30 1.4ml/min30
13 IEC-HPLC
HPLC RSD (n=6)0.17%RSD (n=6 )0.09%
-1 -1 -1
5 mg•mL ) 10 mg•mL ) 15 mg•mL ) 96.2
% ,98.8% ,100.3%98.4%2 mg•mL-1~20 mg•mL-1 r=1.0000
HPLC 13
IEC-HPLC 2 r 1.000P0.05
HPLC IEC-HPLC
HPLC
Key words: sucrose; blood product; human fibrinogen, ion exchange HPLC, dry-heat treatment
HPLC method for quantitative analysis of sucrose in human fibrinogen
WANG Min-li, YANG Peng-yun, WANG Qing-zhou, ZHAO hui, HOU Ji-feng
(National Institutes for Food and Drug Control, Key Laboratory of the Ministry of
Health for Research on Quality and Standardization of Biotech Products, Beijing
100050, China)
Abstract
1 *
Tel: 86-10- Fax:86-10 E-mail
houjf@nicpbp.org.cn
Objective: To establish the quantitative determination method of sucrose by HPLC in human
fibrinogen.
Methods: A HPLC method has been developed to specifically determine sucrose on Zorbax
carbohydrate analysis column with Waters Alliance system and 2414 refractive index detector. The
separations were performed at 30 using a mobile phase of acetonitrile and water (70:30) as
elution with flow rate of 1.4mL•min-1.13 batches of recombinant human coagulation factor
were selected for comparison test with the IEC-HPLC method issued in CHP2010. These products
only contain sucrose and with no dry-heat treatment which makes it possible to do methodology
comparison with the established HPLC method.
Results: Sucrose standard solution was injected for 6 times to get precision r
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