Stable-isotope dilution LC-MS/MS assay for determination of iloperidone and its two major metabolites, P 88 and P 95, in human plasma: application to a bioequivalence study
Autor: | Jignesh M. Parekh, Manish Yadav, Mallika Sanyal, Pranav S. Shrivastav |
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Rok vydání: | 2013 |
Předmět: |
Analyte
Clinical Biochemistry Isotope dilution Analytical Chemistry Matrix (chemical analysis) Bioequivalence study Iloperidone Piperidines Tandem Mass Spectrometry Lc ms ms medicine Humans General Pharmacology Toxicology and Pharmaceutics Chromatography High Pressure Liquid Chromatography Chemistry Extraction (chemistry) Solid Phase Extraction General Medicine Isoxazoles Deuterium Medical Laboratory Technology Therapeutic Equivalency Human plasma Area Under Curve Isotope Labeling Calibration medicine.drug Antipsychotic Agents Half-Life |
Zdroj: | Bioanalysis. 5(6) |
ISSN: | 1757-6199 |
Popis: | Background: Iloperidone is a novel antipsychotic drug with high affinity for serotonin and D2 dopamine receptors. A sensitive and rapid isotope dilution LC–MS/MS method has been developed for the simultaneous determination of iloperidone and its two major metabolites in human plasma. Results: The analytes and their deuterated analogs as internal standards were quantitatively extracted from 100-µl human plasma by SPE. The method was validated over the concentration range of 0.01–6 ng/ml for all the analytes. Baseline separation of analytes was possible within 3 min on ACE 5 C8 column. The accuracy and precision (%CV) of the method varied from 96.2 to 105%, and 1.17 to 4.75%, respectively. The extraction recovery was >84%, while the internal standard-normalized matrix factors ranged from 0.97–1.03 for all three analytes. Conclusion: The developed method was successfully applied to support a bioequivalence study in healthy volunteers. |
Databáze: | OpenAIRE |
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