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A reversed‐phase high‐performance liquid chromatography method for bovine serum albumin assay in pharmaceutical dosage forms and protein/antigen delivery systems
Author(s) -
Hamidi Mehrdad,
Zarei Najmeh
Publication year - 2009
Publication title -
drug testing and analysis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.065
H-Index - 54
eISSN - 1942-7611
pISSN - 1942-7603
DOI - 10.1002/dta.33
Subject(s) - chromatography , bovine serum albumin , chemistry , dosage form , high performance liquid chromatography , serum albumin , delivery system , pharmacology , biochemistry , medicine
Abstract Bovine serum albumin (BSA) is among the most widely used proteins in protein formulations as well as in the development of novel delivery systems as a typical model for therapeutic/diagnostic proteins and the new versions of vaccines. The development of reliable and easily available assay methods for quantitation of this protein would therefore play a crucial role in these types of studies. A simple gradient reversed‐phase high‐performance liquid chromatography with ultra‐violet detection (HPLC‐UV) method has been developed for quantitation of BSA in dosage forms and protein delivery systems. The method produced linear responses throughout the wide BSA concentration range of 1 to 100 µ g/mL. The average within‐run and between‐run variations of the method within the linear concentration range of BSA were 2.46% and 2.20%, respectively, with accuracies of 104.49% and 104.58% for within‐run and between‐run samples, respectively. The limits of detection (LOD) and quantitation (LOQ) of the method were 0.5 and 1 µg/mL, respectively. The method showed acceptable system suitability indices, which enabled us to use it successfully during our particulate vaccine delivery research project. Copyright © 2009 John Wiley & Sons, Ltd.