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
Rok vydání: 2013
Předmět:
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