Development and validation of a high-throughput and robust LC-MS/MS with electrospray ionization method for simultaneous quantitation of oseltamivir phosphate and its oseltamivir carboxylate metabolite in human plasma for pharmacokinetic studies

Biomedical Chromatography

Volumn 25, Issue 6, 2011, Pages 727-733

  Kanneti, Ravi ^a,b   Bhavesh, Dasandi ^c   Paramar, Dharmesh ^c   R, Shivaprakash ^c   Bhatt, Parloop A ^a  

^a GUJARAT UNIVERSITY   (India)

^b DR REDDY'S LABORATORIES LTD   (India)

^c Synchron Research Services Pvt Ltd   (India)

Author keywords

Electro Spray Ionization; Human plasma; LC MS MS; OC; OP

Indexed keywords

CARBOXYLATION; EXTRACTION; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; PHASE SEPARATION; PLASMA (HUMAN); QUALITY CONTROL; VIRUSES;

ELECTRO-SPRAY IONIZATION; HIGH-THROUGHPUT; HUMAN PLASMAS; LC-MS-MS; LC.MS/MS; OSELTAMIVIR CARBOXYLATE; OSELTAMIVIR PHOSPHATES; PHARMACOKINETIC STUDIES; SOLID-PHASE EXTRACTION; ULTRAPERFORMANCE LIQUID CHROMATOGRAPHY-TANDEM MASS SPECTROMETRIES;

ELECTROSPRAY IONIZATION;

4 ACETAMIDO 5 AMINO 3 (1 ETHYLPROPOXY) 1 CYCLOHEXENE 1 CARBOXYLIC ACID; ACICLOVIR; DRUG METABOLITE; OSELTAMIVIR;

ACCURACY; ANALYTIC METHOD; ARTICLE; CONCENTRATION (PARAMETERS); DRUG BLOOD LEVEL; DRUG DETERMINATION; DRUG ISOLATION; DRUG SELECTIVITY; DRUG STRUCTURE; ELECTROSPRAY; HIGH THROUGHPUT SCREENING; HUMAN; PHARMACOKINETICS; QUANTITATIVE ASSAY; REPRODUCIBILITY; SOLID PHASE EXTRACTION; TANDEM MASS SPECTROMETRY; TECHNIQUE; ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY; VALIDITY;

EID: 79955759563     PISSN: 02693879     EISSN: 10990801     Source Type: Journal    
DOI: 10.1002/bmc.1509     Document Type: Article

References (12)

1. Bahrami G, Mohammadi B and Kiani A. Determination of oseltamivir carboxylic acid in human serum by solid phase extraction and high performance liquid chromatography with UV detection. Journal of Chromatography B 2008; 864: 38-42.
2. Dams R, Huestis MA, Lambert WE and Murphy CM. Matrix effect in bio-analysis of illicit drugs with LC-MS/MS: influence of ionization type, sample preparation, and biofluid. Journal of the American Society for Mass Spectrometry 2003; 14: 1290-1294.
3. FDA. Guidance for Industry. Bioanalytical Method Validation. US Department of Health and Human Services, FDA, CDER, CVM, 2001; available at
4. He G, Massarella J and Ward P. Clinical pharmacokinetics of the prodrug oseltamivir and its active metabolite Ro 64-0802. Clinical Pharmacokinetics 1999; 37: 471-484.
5. Heinig K and Bucheli F. Sensitive determination of oseltamivir and oseltamivir carboxylate in plasma, urine, cerebrospinal fluid and brain by liquid chromatography-tandem mass spectrometry. Journal of Chromatography B 2008; 876: 129-136.
6. Hill G, Cihlar T, Oo C, Ho ES, Prior K, Wiltshire H, Barrett J, Liu B and Ward P. The anti-influenza drug oseltamivir exhibits low potential to induce pharmacokinetic drug interactions via renal secretion-correlation of in vivo and in vitro studies. Drug Metabolism and Disposition 2002; 30: 13-19.
7. Lindegardh N, Hanpithakpong W, Wattanagoon Y, Singhasivanon P, White NJ, Day NPJ. Development and validation of a liquid chromatographic-tandem mass spectrometric method for determination of oseltamivir and its metabolite oseltamivir carboxylate in plasma, saliva and urine. Journal of Chromatography B 2007; 859: 74-83.
8. Matuszewski BK, Constanzer ML and Chavez CM. Strategies for the assessment of matrix effect in quantitative bioanalytical methods based on HPLC-MS/MS. Analytical Chemistry 2003; 75: 3019-3030.
9. Shah VP, Midha KK, Dighe S, McGilveray IJ, Skelly JP, Yacobi A etal. Analytical methods validation: bioavailability, bioequivalence and pharmacokinetic studies. Conference report. European Journal of Drug Metabolism and Pharmacokinetics 1991; 16: 249.
10. Shinde V, Bridges CB, Uyeki TM, Shu B, Balish A, Xu X, Lindstrom S, Gubareva LV, Deyde V, Garten RJ, Harris M, Gerber S, Vagasky S, Smith F, Pascoe N, Martin K, Dufficy D, Ritger K, Conover C, Quinlisk P, Klimov A, Bresee JS and Finelli L. Triple-reassortant swine influenza A (H1) in humans in the United States, 2005-2009. The New England Journal of Medicine 2009; 360(25): 2616-2625.
11. Viswanathan CT, Bansal S, Booth B, DeStefano AJ, Rose MJ, Sailstad J, Shah VP, Skelly JP, Swann PG and Weiner R. Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays. AAPS Journal 2007; 9(1): E30-E42.
12. Wiltshire H, Wiltshire B, Citron A, Clarke T, Serpe C, Gray D and Herron W. Development of a high-performance liquid chromatographic-mass spectrometric assay for the specific and sensitive quantification of Ro 64-0802, an anti-influenza drug, and its pro-drug, oseltamivir in human and animal plasma and urine. Journal of Chromatography B: Biomedical Science and Applications 2000; 745: 373-388.