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

Bioanalysis

Volumn 5, Issue 6, 2013, Pages 669-686

  Parekh, Jignesh M ^a   Sanyal, Mallika ^b   Yadav, Manish ^c   Shrivastav, Pranav S ^a,d  

^a Kadi Sarva Vishwa Vidyalaya   (India)

^b ST XAVIER S COLLEGE   (India)

^c Cadila Pharmaceuticals Ltd   (India)

^d GUJARAT UNIVERSITY   (India)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG METABOLITE; ILOPERIDONE; PIPERIDINE DERIVATIVE;

ACCURACY; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG DETERMINATION; DRUG ELIMINATION; DRUG HALF LIFE; DRUG STABILITY; HUMAN; HUMAN EXPERIMENT; ISOTOPE DILUTION ASSAY; LIMIT OF DETECTION; LIMIT OF QUANTITATION; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; OPEN STUDY; PLASMA CONCENTRATION-TIME CURVE; RANDOMIZED CONTROLLED TRIAL; REPRODUCIBILITY; SENSITIVITY AND SPECIFICITY; SIGNAL NOISE RATIO; SINGLE DRUG DOSE; SOLID PHASE EXTRACTION; TABLET FORMULATION;

ANTIPSYCHOTIC AGENTS; AREA UNDER CURVE; CALIBRATION; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DEUTERIUM; HALF-LIFE; HUMANS; ISOTOPE LABELING; ISOXAZOLES; PIPERIDINES; SOLID PHASE EXTRACTION; TANDEM MASS SPECTROMETRY; THERAPEUTIC EQUIVALENCY;

EID: 84875047021     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.13.25     Document Type: Article

References (20)

1. Crabtree BL, Montgomery J. Iloperidone for the management of adults with schizophrenia, Clin. Ther. 33, 330-345 (2011).
2. Citrome L. Iloperidone: chemistry, pharmacodynamics, PKs and metabolism, clinical efficacy, safety and tolerability, regulatory affairs, and an opinion. Expert Opin. Drug Metab. Toxicol. 6, 1551-1564 (2010).
3. Caccia SL, Pasina L, Nobili A. New atypical antipsychotics for schizophrenia: iloperidone. Drug Des. Devel. Ther. 4, 33-48 (2010).
4. Subramanian N, Kalkman HO. Receptor profile of P88-8991 and P95-12113, metabolites of the novel antipsychotic iloperidone. Prog. Neuropsychopharmacol. Biol. Psychiatry 26, 553-560 (2002).
5. Sainati SM, Hubbard JW, Chi E, Grasing K, Brecher MB. Safety, tolerability, and effect of food on the PKs of iloperidone (HP 873), a potential atypical antipsychotic. J. Clin. Pharmacol. 35, 713-720 (1995).
6. Marino J, Caballero J. Iloperidone for the treatment of schizophrenia. Ann. Pharmacother. 44, 863-870 (2010).
7. Venkatamahesh R, Perumal RV, Babu CJG, Revathi R, Muneer S, Channabasavaraj KP. Development and validation of derivative UV spectrophotometric methods for quantitative estimation of iloperidone in bulk and pharmaceutical dosage form. Am. J. PharmTech. Res. 1, 311-316 (2011).
8. Chhalotiya UK, Bhatt KK, Shah DA, Patel Jr. Liquid chromatographic method for the quantification of antipsychotic agent iloperidone in pharmaceutical formulation. ISRN Anal. Chem. Article ID 963276 (2012).
9. Mutlib AE, Strupczewski JT, Chesson SM. Application of hyphenated LC/NMR and LC/MS techniques in rapid identification of in vitro and in vivo metabolites of iloperidone. Drug Metab. Dispos. 23, 951-964 (1995).
10. Mutlib AE, Strupczewski JT. Picogram determination of iloperidone in human plasma by solid-phase extraction and by high-performance liquid chromatography-selected ion monitoring electrospray mass spectrometry. J. Chromatogr. B 669, 237-246 (1995).
11. Wolfgang C. Genotyping facilitates individualized prediction of PK exposure of iloperidone in extensive and poor metabolizers (poster presentation NR-508). Presented at: 160th Annual Meeting of the American Psychiatric Association. San Diego, CA, USA, 19-24 May 2007.
12. Guidance for Industry, Bionanlytical Method Validation, US Department of Health and Human Services, Food and Drug Administration Centre for Drug Evaluation and Research (CDER), Centre for Veterinary Medicine (CVM), May 2001.
13. King R, Bonfiglio R, Fernandez-Metzler C, Miller-Stein C, Olah T. Mechanistic investigation of ionization suppression in electrospray ionization, J. Am. Soc. Mass Spectrom. 11, 842-950 (2000).
14. Matuszewski BK. Standard line slopes as a measure of relative matrix effect in quantitative HPLC-MS bioanalysis. J. Chromatogr. B 830, 293-300 (2006).
15. Guidance for Industry: ICH E6 Good Clinical Practice, U.S. Department of Health and Human Services, Food and Drug Administration, Centre for Drug Evaluation and Research (CDER), Centre for Biologics Evaluation and Research (CBER), 1996.
16. Yadav M, Shrivastav PS. Incurred sample reanalysis: a decisive tool in bioanalytical research. Bioanalysis 3(9), 1007-1024 (2011).
17. Bansal S, DeStefano A. Key elements of bioanalytical method validation for small molecules. AAPS J. 9, E109-114 (2007).
18. US FDA. Drug Approval Package. Fanapt™ (iloperidone) tablets, 12 June 2009. www.fda.gov/drugsatfda-docs/nda/2009/022192s000TOC.cfm(accessed 5 October 2012)
19. Fanapt™ (iloperidone), Full Prescribing Information, Vanda Pharmaceuicals Inc., used by Novartis Pharmaceuticals Corporation, January 2012.www.pharma.us.novartis.com/ product/pi/pdf/fanapt.pdf (accessed 5 October 2012)
20. Draft Guidance on iloperidone, Office of Generic Drugs, US FDA, Recommended November 2010. www.fda.gov/downloads/Drugs/ Guidance Compliance Regulatory Information/Guidances/UCM234968.pdf(accessed 5 October 2012)