Selection of an analytical method for evaluating bovine serum albumin concentrations in pharmaceutical polymeric formulations

Manish Umrethia, Victoria Kett, Gavin Andrews, Karl Malcolm, David Woolfson

Research output: Contribution to journalArticle

24 Citations (Scopus)

Abstract

Bovine serum albumin (BSA) is a commonly used model protein in the development of pharmaceutical formulations. In order to assay its release from various dosage forms, either the bicinchoninic acid (BCA) assay or a more specific size-exclusion high performance liquid chromatography (SE-HPLC) method are commonly employed. However, these can give erroneous results in the presence of some commonly-used pharmaceutical excipients. We therefore investigated the ability of these methods to accurately determine BSA concentrations in pharmaceutical formulations that also contained various polymers and compared them with a new and compared with a new reverse-phase (RP)–HPLC technique. We found that the RP-HPLC technique was the most suitable method. It gave a linear response in the range of 0.5 -100 µg/ml with a correlation coefficient of 0.9999, a limit of detection of 0.11 µg/ml and quantification of 0.33 µg/ml. The performed ‘t’ test for the estimated and theoretical concentration indicated no significant difference between them providing the accuracy. Low % relative standard deviation values (0.8-1.39%) indicate the precision of the method. Furthermore, the method was used to quantify in vitro BSA release from polymeric freeze-dried formulations.
Original languageEnglish
Pages (from-to)1175-1179
Number of pages5
JournalJournal of Pharmaceutical and Biomedical Analysis
Volume1
Issue number5
DOIs
Publication statusPublished - 06 Apr 2010

ASJC Scopus subject areas

  • Analytical Chemistry
  • Drug Discovery
  • Pharmaceutical Science
  • Spectroscopy
  • Clinical Biochemistry

Fingerprint Dive into the research topics of 'Selection of an analytical method for evaluating bovine serum albumin concentrations in pharmaceutical polymeric formulations'. Together they form a unique fingerprint.

  • Cite this