Novel strategy using tryptic peptide immunoaffinity-based LC-MS/MS to quantify denosumab in monkey serum.
Bioanalysis
; 9(19): 1451-1463, 2017 Oct.
Article
in En
| MEDLINE
| ID: mdl-29056058
ABSTRACT
AIM:
Denosumab is a recombinant fully human IgG2 that has a high affinity and specificity for human RANKL. Commercially available RANKL labeled with an Fc fragment cannot be used to establish an indirect ELISA. To characterize denosumab pharmacokinetic a robust and accuracy method should be developed urgently.RESULTS:
In this study, an immunoaffinity enrichment method coupled with LC-MS/MS was established. The LC-MS/MS method acquired a linear range from 0.1 to 30 µg/ml. The intra- and inter-run precision (CV%) was within 11.5 and 10.5%, respectively. More importantly, the LC-MS/MS pharmacokinetic data were consistent with ELISA.CONCLUSION:
This approach accelerated the quantification, reduced the costs and provided an alternative in case of lacking the special antigen to denosumab or a RANKL-biotinylated reagent.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Peptides
/
Blood Chemical Analysis
/
Trypsin
/
Denosumab
Limits:
Animals
Language:
En
Journal:
Bioanalysis
Year:
2017
Document type:
Article