Development and validation of an UPLC-MS/MS method for the simultaneous determination of fexofenadine and olmesartan in human serum: Application to in vivo pharmacokinetic studies.
J Pharm Biomed Anal
; 245: 116179, 2024 Aug 01.
Article
in En
| MEDLINE
| ID: mdl-38703749
ABSTRACT
A sensitive, reproducible, robust, high-throughput ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method was developed and validated for the simultaneous quantification of fexofenadine and olmesartan in human serum. Samples (50⯵L) undergo protein precipitation prior to UPLC-MS/MS analysis. The analytes were separated using an Acquity BEH C18 column (2.1â¯mm × 50â¯mm, 1.7⯵m) at a flow rate of 0.5â¯mL/min using a gradient elution with a total run time of 4â¯min. The analytes were detected in positive ion mode and selected reaction monitoring (SRM) was used for quantitation. The standard curve concentration range was 1.0-500.0â¯ng/mL for both analytes and each analyte showed excellent linearity with correlation coefficients (R2 > 0.99). The intra- and inter-day accuracy and precision were ±15% for each analyte, and excellent recovery was demonstrated (93-98%) for both analytes. The method is well suited for high-throughput quantitative determination of fexofenadine and olmesartan simultaneously and was successfully applied to an in vivo pharmacokinetic and transporter phenotyping study in humans.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Tetrazoles
/
Terfenadine
/
Tandem Mass Spectrometry
/
Imidazoles
Limits:
Humans
Language:
En
Journal:
J Pharm Biomed Anal
Year:
2024
Document type:
Article