Quantitative analysis of sucrose in human fibrinogen by HPLC / 中国药学杂志
Chinese Pharmaceutical Journal
;
(24): 569-572, 2013.
Artigo
em Chinês
| WPRIM
| ID: wpr-860434
ABSTRACT
OBJECTIVE:
To establish a quantitative determination method of sucrose in human fibrinogen by HPLC.METHODS:
An HPLC method was developed to specifically determine sucrose on Zorbax carbohydrate analysis column with Waters Alliance system and 2414refractive index detector. The separation was performed at 30°C using a mobile phase consisting of acetonitrile and water (7030) at a flow rate of 1.4 mL · min-1. Thirteen batches of recombinant human coagulation factor VM samples were selected for methodology comparison of the established HPLC method with the IEC-HPLC method adopted by Ch. P 2010, because these samples only contained sucrose and did not receive dry-heat treatment.RESULTS:
The RSDs (n=6) of the retention time and peak area were 0.17% and 0.09%, respectively. The recoveries of sucrose at low (5 mg · mL-1), middle (10 mg · mL-1), high (15 mg · mL-1) concentration were 96.2%, 98.8% and 100.3%, respectively. The average recovery was 98.4% and the linear correlation coefficient r was 1.0000 in the ranges of 2-20 mg · mL-1. Statistical analysis showed that the amounts of sucrose in 13 batches of recombinant human coagulation factor VIII samples determined by the HPLC method and IEC-HPLC method had no significant difference (P≤0.05) and the correlation coefficient r was 1.0000.CONCLUSION:
The proposed HPLC method is simple, accurate and re-peatable for determination of sucrose in dry-heat treated human fibrinogen product. The HPLC method showed good accordance with IEC-HPLC method for assay results of sucrose, thus can be widely applied.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Idioma:
Chinês
Revista:
Chinese Pharmaceutical Journal
Ano de publicação:
2013
Tipo de documento:
Artigo
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