LC-MS/MS method development for quantification of busulfan in human plasma and its application in pharmacokinetic study

Journal of Pharmaceutical and Biomedical Analysis

Volumn 120, Issue , 2016, Pages 168-174

  Nadella, Taraka Ramarao ^a   Suryadevara, Vidyadhara ^b   Lankapalli, Sasidhar Reddyvallam ^b   Mandava, Venkata Basaveswara Rao ^c   Bandarupalli, Deepti ^d  

^a Maharashtra Industrial Development Corporation India   (India)

^b CHEBROLU HANUMAIAH INSTITUTE OF PHARMACEUTICAL SCIENCES   (India)

^c KRISHNA UNIVERSITY   (India)

^d VIGNAN PHARMACY COLLEGE   (India)

Author keywords

Busulfan; Busulfan d8; Human plasma; LC MS MS; Validation

Indexed keywords

AMMONIUM FORMATE; BUSULFAN;

ACCURACY; ARTICLE; CONTROLLED STUDY; DRUG SELECTIVITY; DRUG STABILITY; FLOW RATE; HUMAN; HUMAN EXPERIMENT; LIMIT OF QUANTITATION; LIQUID CHROMATOGRAPHY; MALE; NORMAL HUMAN; PLASMA; PRIORITY JOURNAL; TABLET FORMULATION; TANDEM MASS SPECTROMETRY; BLOOD; MASS SPECTROMETRY; ORAL DRUG ADMINISTRATION; PROCEDURES; TRENDS;

ADMINISTRATION, ORAL; BUSULFAN; CHROMATOGRAPHY, LIQUID; HUMANS; MALE; MASS SPECTROMETRY; TANDEM MASS SPECTROMETRY;

EID: 84951743005     PISSN: 07317085     EISSN: 1873264X     Source Type: Journal    
DOI: 10.1016/j.jpba.2015.12.024     Document Type: Article

References (11)

1. Vassal G., Deroussent A., Hartmann O. Dose-dependent neurotoxicity of high-dose busulfan in children: a clinical and pharmacological study. Cancer Res. 1990, 50(19):6203-6207.
2. Bearman S.I. The syndrome of hepatic veno-occlusive disease after marrow transplantation. Blood 1995, 85(11):3005-3020.
3. Desire S., Pavai Mohanan E., George B., Mathews V., Chandy M., Srivastava A., Balasubramanian P. A rapid & sensitive liquid chromatography- tandem mass spectrometry method for the quantitation of busulfan levels in plasma & application for routine therapeutic monitoring in haematopoietic stem cell transplantation. Indian J. Med. Res. 2013, 137:777-784.
4. Lin H., Goodin S., Strair R.K., DiPaola R.S., Gounder M.K. Comparison of LC-MS assay and HPLC assay of busulfanin clinical pharmacokinetics studies. ISRN Anal. Chem. 2012, 1-5.
5. Moon S.Y., Lim M.K., Hong S., Jeon Y. Quantification of human plasma-busulfan concentration by liquid chromatography-tandem mass spectrometry. Ann. Lab. Med. 2014, 34:7-14.
6. Quernin M.H., Poonkuzhali B., Medard Y., Dennison D., Srivastava A., Krishnamoorthy R., Chandy M., Jacqz-Aigrain E. High performance liquid chromatography method for quantification of busulfan in plasma after dervitixation by tetraflurothiophenol. J. Chromatogr. B Biomed. Sci. Appl. 1999, 721(1):147-152.
7. Lin H., Goodin S., Strair R.K., DiPaola R.S., Gounder M.K. Comparison of LC-MS assay and HPLC assay of busulfan in clinical pharmacokinetics studies. ISRN Anal. Chem. 2012, 2012:1-5.
8. Desire S., Mohanan E.P., George B., Mathews V., Chandy M., Srivastava A., Balasubramanian P. A rapid & sensitive liquid chromatography- tandem mass spectrometry method for the quantitation of busulfan levels in plasma & application for routine therapeutic monitoring in haematopoietic stem cell transplantation. Indian J Med Res. 2013, 137(4):777-784.
9. Guidance for Industry: Bioanalytical Method Validation, U.S. Department of Health and Human Services, Food and Drug Administration Centre for Drug Evaluation and Research (CDER), Centre for Veterinary Medicine (CVM). May (2001).
10. ICH Text on validation of analytical procedures, Q2A (R1). International Conference onHarmonization, IFPMA, Geneva (1994).
11. FDA. Guidance for industry Bioanalytical Method Validation. US Food and Drug Administration Center for Evaluation and Research (2001).