Simultaneous determination of desloratadine and its active metabolite 3-hydroxydesloratadine in human plasma by LC/MS/MS and its application to pharmacokinetics and bioequivalence.
J Pharm Biomed Anal
; 45(4): 659-66, 2007 Nov 30.
Article
in En
| MEDLINE
| ID: mdl-17936534
ABSTRACT
A rapid and simple liquid chromatographic-tandem mass spectrometric (LC/MS/MS) method was developed and validated for the simultaneous determination of desloratadine and its active metabolite 3-hydroxydesloratadine concentrations in human plasma. After liquid-liquid extraction with ethyl ether for sample preparation, the chromatographic separation was achieved on a CAPCELL PAK C18 column (50 mm x 2.0mm, 5 microm, Shiseido). [(2)H(4)]desloratadine and [(2)H(4)]3-OH desloratadine were used as internal standards. A mobile phase consisted of 5mM ammonium formate in water, methanol and acetonitrile (503020). Detection was by positive ion electrospray tandem mass spectrometry on a Sciex API3000. A quadratic regression (weighted 1/concentration) gave the best fit for calibration curves over the concentration range 0.05-10 ng/mL for both desloratadine and 3-OH desloratadine. The method was shown to be accurate, rapid and sufficiently sensitive to be successfully applied to a pharmacokinetic and bioequivalent study.
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Collection:
01-internacional
Database:
MEDLINE
Main subject:
Loratadine
Type of study:
Clinical_trials
/
Diagnostic_studies
Limits:
Humans
/
Male
Language:
En
Journal:
J Pharm Biomed Anal
Year:
2007
Document type:
Article