Application of a validated ultra performance liquid chromatography-tandem mass spectrometry method for the quantification of darunavir in human plasma for a bioequivalence study in Indian subjects

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

Volumn 879, Issue 24, 2011, Pages 2443-2453

  Gupta, Ajay ^a,b   Singhal, Puran ^b   Shrivastav, Pranav S ^c   Sanyal, Mallika ^a,d  

^a Kadi Sarva Vishwa Vidyalaya   (India)

^b Veeda Clinical Research India   (India)

^c GUJARAT UNIVERSITY   (India)

^d ST XAVIER S COLLEGE   (India)

Author keywords

Bioequivalence study; Darunavir; Human plasma; Incurred sample reanalysis; UPLC MS MS

Indexed keywords

BIOEQUIVALENCE STUDY; DARUNAVIR; HUMAN PLASMAS; INCURRED SAMPLE REANALYSIS; UPLC-MS/MS;

ETHERS; IONS; LIQUIDS; MASS SPECTROMETRY; PLASMA (HUMAN); PLASMAS; SOLVENT EXTRACTION;

LIQUID CHROMATOGRAPHY;

DARUNAVIR; DARUNAVIR D9; PROTEINASE INHIBITOR; RITONAVIR; TERT BUTYL METHYL ETHER; UNCLASSIFIED DRUG;

ACCURACY; ANALYTIC METHOD; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BLOOD SAMPLING; DENSITY GRADIENT; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DETERMINATION; DRUG HALF LIFE; DRUG METABOLISM; DRUG STABILITY; HUMAN; HUMAN EXPERIMENT; INDIAN; LIMIT OF QUANTITATION; LIQUID LIQUID EXTRACTION; LOW DRUG DOSE; MASS SPECTROMETER; MAXIMUM PLASMA CONCENTRATION; MULTIPLE REACTION MONITORING; NORMAL HUMAN; PARTICLE SIZE; PHASE TRANSITION; PRIORITY JOURNAL; PRODUCT RECOVERY; REACTION ANALYSIS; REPRODUCIBILITY; SENSITIVITY ANALYSIS; SINGLE DRUG DOSE; TABLET FORMULATION; TANDEM MASS SPECTROMETRY; TIME TO MAXIMUM PLASMA CONCENTRATION; ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY; VALIDATION PROCESS;

CHROMATOGRAPHY, HIGH PRESSURE LIQUID; HUMANS; INDIA; SULFONAMIDES; TANDEM MASS SPECTROMETRY; THERAPEUTIC EQUIVALENCY;

EID: 79960990825     PISSN: 15700232     EISSN: 1873376X     Source Type: Journal    
DOI: 10.1016/j.jchromb.2011.07.008     Document Type: Article

References (31)

1. De Meyer S., Azijn H., Surleraux D., Jochmans D., Tahri A., Pauwels R., Wigerinck P., De Bethune M.P. Antimicrob. Agents Chemother. 2007, 49:2314.
2. Koh Y., Nakata H., Maeda K., Ogata H., Bilcer G., Devasamudram T., Kincaid J.F., Boross P., Wang Y.-F., Tie Y., Volarath P., Gaddis L., Harrison R.W., Weber I.T., Ghosh A.K., Mitsuya H. Antimicrob. Agents Chemother. 2003, 47:3123.
3. Sekar V.J., Lefebvre E., De Pauw M., Vangeneugden T., Hoetelmans R.M. Br. J. Clin. Pharmacol. 2008, 66:215.
4. Vermeir M., Lachau-Durand S., Manners G., Cuyckens F., van Hoof B., Raoof A. Drug Metab. Dispos. 2009, 37:809.
5. Poveda E., Blanco F., Garcia-Gasco P., Alcolea A., Briz V., Soriano V. AIDS 2006, 20:1558.
6. Cooper C.L., van Heeswijk R.P., Gallicano K., Cameron D.W. Clin. Infect. Dis. 2003, 36:1585.
7. Youle M. J. Antimicrob. Chemother. 2007, 60:1195.
8. Yilmaz A., Izadkhashti A., Price R.W., Mallon P.W., De Meulder M., Timmerman P., Gisslen M. AIDS Res. Hum. Retroviruses 2009, 25:457.
9. Delaugerre C., Peytavin G., Dominguez S., Marcelin A.G., Duvivier C., Gourlain K., Amellal B., Legrand M., Raffi F., Costagliola D., Katlama C., Calvez V. J. Med. Virol. 2005, 77:345.
10. Takahashi M., Kudaka Y., Okumura N., Hirano A., Banno K., Kaneda T. Biol. Pharm. Bull. 2007, 30:1947.
11. Goldwirt L., Chhuna S., Rey E., Launay O., Viard J.-P., Pons G., Jullien V. J. Chromatogr. B 2007, 857:327.
12. Sekar V.J., Lefebvre E., De Paepe E., De Marez T., De Pauw M., Parys W., Hoetelmans R.M. Antimicrob. Agents Chemother. 2007, 51:958.
13. Rezk N.L., White N.R., Jennings S.H., Kashuba A.D.M. Talanta 2009, 79:1372.
14. Fayet A., Béguin A., Zanolari B., Cruchon S., Guignard N., Telenti A., Cavassini M., Günthard H.F., Buclin T., Biollaz J., Rochat B., Decosterd L.A. J. Chromatogr. B 2009, 877:1057.
15. ter Heine R., Rosing H., van Gorp E.C.M., Mulder J.W., van der Steeg W.A., Beijnen J.H., Huitema A.D.R. J. Chromatogr. B 2008, 867:205.
16. ter Heine R., Alderden C.G., Rosing H., Hillebrand M.J., van Gorp E.C., Huitema A.D., Beijnen J.H. Rapid Commun. Mass Spectrom. 2007, 21:2505.
17. D'Avolio A., Siccardi M., Sciandra M., Baietto L., Bonora S., Trentini L., Di Perri G. J. Chromatogr. B 2007, 859:234.
18. Martin J., Deslandes G., Dailly E., Renaud C., Reliquet V., Raffi F., Jolliet P. J. Chromatogr. B 2009, 877:3072.
19. D'Avolio A., Simiele M., Siccardi M., Baietto L., Sciandra M., Bonora S., Di Perri G. J. Pharm. Biomed. Anal. 2010, 52:774.
20. Else L., Watson V., Tjia J., Hughes A., Siccardi M., Khoo S., Back D. J. Chromatogr. B 2010, 878:1455.
21. ter Heine R., Davids M., Rosing H., van Gorp E.C.M., Mulder J.W., van der Heide Y.T., Beijnen J.H., Huitema A.D.R. J. Chromatogr. B 2009, 877:575.
22. D'Avolio A., Simiele M., Siccardi M., Baietto L., Sciandra M., Oddone V., Stefani F.R., Agati S., Cusato J., Bonora S., Di Perri G. J. Pharm. Biomed. Anal. 2011, 54:779.
23. Chesnut S.M., Salisbury J.J. J. Sep. Sci. 2007, 30:1183.
24. Wu N., Clausen A.M. J. Sep. Sci. 2007, 30:1167.
25. Guidance for Industry, Bioanalytical 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.
26. Matuszewski B.K., Constanzer M.L., Chavez-Eng C.M. Anal. Chem. 2003, 75:3019.
27. 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), April 1996.
28. Rocci M.L., Devanarayan V., Haughey D.B., Jardieu P. AAPS J. 2007, 9:E336.
29. Lubda D., Cabrera K., Kraas W., Shaefer C., Cunningham D. LC-GC Eur. 2001, 12:1.
30. Sekar V., Guzman S., Stevens T., De Paepe E., Lefebvre E., Hoetelmans R. 7th International Workshop on Clinical Pharmacology of HIV Therapy 2006, Abstract P86.
31. Sekar V., Kestens D., Spinosa-Guzman S., De Pauw M., De Paepe E., Vangeneugden T., Lefebvre E., Hoetelmans R. J. Clin. Pharmacol. 2007, 47:479.