Validated LC-MS/MS Method for Simultaneous Quantitation of SAFit-1 and SAFit-2 in Mice Plasma: Application to a Pharmacokinetic Study.
Drug Res (Stuttg)
; 70(7): 325-332, 2020 Jul.
Article
in En
| MEDLINE
| ID: mdl-32403135
ABSTRACT
SAFit-1 and SAFit-2 are selective FKBP51 (FK506-binding protein 51) ligands. In this paper, we present the development and validation data of an LC-MS/MS method for the simultaneous quantitation of SAFit-1 and SAFit-2 in mice plasma as per FDA regulatory guideline. SAFit-1 and SAFit-2 along with internal standard were extracted from mice plasma using liquid-liquid extraction method. Chromatographic resolution of SAFit-1, SAFit-2 and the internal standard (warfarin) was achieved on an X-Terra phenyl column using 0.2% formic acidacetonitrile (2080, v/v) as an eluent, which was delivered at a flow-rate of 0.9 mL/min. The MS/MS ion transitions monitored were m/z 748.4â420.4, 803.7â384.3 and 309.2 â163.2 for SAFit-1, SAFit-2 and the internal standard, respectively. The linearity range was 2.45-2446 ng/mL for both SAFit-1 and SAFit-2. The intra- and inter-day accuracy and intra- and inter-day precision were in the range of 0.90-1.07 and 2.38-10.8%, respectively for SAFit-1; 0.97-1.15 and 0.23-12.5%, respectively for SAFit-2. Both SAFit-1 and SAFit-2 were found to be stable in stability studies (up to three freeze-thaw cycles and for long-term at -80°C for 30 days) and processed (bench-top for 3 h and in in-injector for 16 h) samples. The application of the validated method was shown in a pharmacokinetic study in mice.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Chemistry, Pharmaceutical
/
Tacrolimus Binding Proteins
/
Antidepressive Agents
Type of study:
Diagnostic_studies
Limits:
Animals
Language:
En
Journal:
Drug Res (Stuttg)
Year:
2020
Document type:
Article
Affiliation country:
India
Publication country:
ALEMANHA
/
ALEMANIA
/
DE
/
DEUSTCHLAND
/
GERMANY