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SPE-UPLC-MS/MS method for sensitive and rapid determination of aripiprazole in human plasma to support a bioequivalence study.
- Source :
-
Journal of chromatography. B, Analytical technologies in the biomedical and life sciences [J Chromatogr B Analyt Technol Biomed Life Sci] 2013 Apr 15; Vol. 925, pp. 20-5. Date of Electronic Publication: 2013 Feb 27. - Publication Year :
- 2013
-
Abstract
- An improved and rugged UPLC-MS/MS method has been developed and validated for sensitive and rapid determination of aripiprazole in human plasma using aripiprazole-d8 as the internal standard (IS). The analyte and IS were extracted from 100 μL of human plasma by solid-phase extraction using Phenomenex Strata-X (30 mg, 1 cc) cartridges. Chromatography was achieved on an Acquity UPLC BEH C18 (50 mm × 2.1 mm, 1.7 μm) analytical column using methanol: 10mM ammonium formate (85:15, v/v) as the mobile phase with isocratic elution. Quantitation was done using multiple reaction monitoring in the positive ionization mode. The linearity of the method was established in the concentration range 0.05-80 ng/mL. The mean extraction recovery was greater than 96% across QC levels, while intra- and inter batch accuracy and precision (% CV) values ranged from 97.4 to 101.9% and from 1.20 to 3.72% respectively. The relative matrix effect in eight different lots of plasma samples, expressed as % CV for the calculated slopes of calibration curves was 1.08%. The stability of aripiprazole was studied under different storage conditions. The validated method was used to support a bioequivalence study of 10mg aripiprazole formulation in 36 healthy Indian subjects.<br /> (Copyright © 2013 Elsevier B.V. All rights reserved.)
- Subjects :
- Aripiprazole
Humans
Linear Models
Piperazines chemistry
Piperazines pharmacokinetics
Quinolones chemistry
Quinolones pharmacokinetics
Reproducibility of Results
Sensitivity and Specificity
Therapeutic Equivalency
Chromatography, High Pressure Liquid methods
Piperazines blood
Quinolones blood
Solid Phase Extraction methods
Tandem Mass Spectrometry methods
Subjects
Details
- Language :
- English
- ISSN :
- 1873-376X
- Volume :
- 925
- Database :
- MEDLINE
- Journal :
- Journal of chromatography. B, Analytical technologies in the biomedical and life sciences
- Publication Type :
- Academic Journal
- Accession number :
- 23510852
- Full Text :
- https://doi.org/10.1016/j.jchromb.2013.02.022