Development and validation of a highly sensitive and robust LC-MS/MS with electrospray ionization method for simultaneous quantitation of itraconazole and hydroxyitraconazole in human plasma: Application to a bioequivalence study

Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences

Volumn 868, Issue 1-2, 2008, Pages 70-76

  Bharathi, D Vijaya ^a,b   Hotha, Kishore Kumar ^b   Sagar, P V Vidya ^b   Kumar, Sanagapati Sirish ^b   Reddy, Pandu Ranga ^b   Naidu, A ^a   Mullangi, Ramesh ^b  

^a JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY   (India)

^b DR REDDY'S LABORATORIES LTD   (India)

Author keywords

Human plasma; Humans; Hydroxyitraconazole; Itraconazole; LC MS MS; Method validation; Pharmacokinetics

Indexed keywords

AMMONIA; CONCENTRATION (PROCESS); ELECTROSPRAY IONIZATION; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; PHARMACOKINETICS; REACTION KINETICS;

HYDROXYITRACONAZOLE; ITRACONAZOLE; METHOD VALIDATION; SOLID PHASE EXTRACTION;

PLASMA (HUMAN);

ACETONITRILE; AMMONIA; FLUCONAZOLE; HYDROXYITRACONAZOLE; ITRACONAZOLE;

ACCURACY; ARTICLE; BIOEQUIVALENCE; CONTROLLED STUDY; DRUG DETERMINATION; ELECTROSPRAY; ELUTION; FLOW RATE; FOOD AND DRUG ADMINISTRATION; FREEZE DRYING; HUMAN; HUMAN EXPERIMENT; INTERDAY PRECISION; INTRADAY PRECISION; LIMIT OF QUANTITATION; LIQUID CHROMATOGRAPHY; MALE; MASS SPECTROMETRY; MULTIPLE REACTION MONITORING MODE; NORMAL HUMAN; PARAMETER; PLASMA; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; SENSITIVITY AND SPECIFICITY; SOLID PHASE EXTRACTION; TECHNIQUE; THAWING; VALIDATION PROCESS;

CHROMATOGRAPHY, LIQUID; HUMANS; ITRACONAZOLE; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; SPECTROMETRY, MASS, ELECTROSPRAY IONIZATION; TANDEM MASS SPECTROMETRY; THERAPEUTIC EQUIVALENCY;

EID: 44449169408     PISSN: 15700232     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jchromb.2008.04.029     Document Type: Article

References (10)

1. Hay R.J., Dupont B., and Graybill J.R. Rev. Infect. Dis. 9 Suppl. (1987) S1
2. Saag M.S., and Dismukes W.E. Antimicrob. Agents Chemother. 32 (1988) 1
3. Haria M., Bryson H.M., and Goa K.L. Drugs 51 (1996) 585
4. Yao M., Chen L., and Srinivas N.R. J. Chromatogr. B 752 (2001) 9
5. Carrier A., and Parent J. J. Chromatogr. B 745 (2000) 413
6. Vogeser M., Spohrer U., and Schiel X. Chem. Lab. Med. 41 (2003) 915
7. Kousoulos C., Tsatsou G., Apostolou C., Dotsikas Y., and Loukas Y.L. Anal. Bioanal. Chem. 384 (2006) 199
8. Guidance for Industry, Bioanalytical Method Validation, US Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER), 2001 Center for Veterinary Medicine (CV), May 2001. http://www/fda.gov/cder/guidance/index.htm.
9. Dams R., Huestis M.A., Lambert W.E., and Murphy C.M. J. Am. Soc. Mass Spectrom. 14 (2003) 1290
10. Hubert Ph., Chiap P., Crommen J., Boulanger B., Chapuzet E., Mercier N., Bervoas-Martin S., Chevalier P., Grandjean D., Lagorce P., Lallier M., Laparra M.C., Laurentie M., and Nivet J.C. Anal. Chim. Acta 391 (1999) 135