LC-APCI mass spectrometric method development and validation for the determination of atovaquone in human plasma

Biomedical Chromatography

Volumn 24, Issue 5, 2010, Pages 497-505

  Gurule, Sanjay ^a   Goswami, Dipanjan ^a   Khuroo, Arshad H ^a   Monif, Tausif ^a  

^a RANBAXY LABORATORIES LTD   (India)

Author keywords

Atovaquone; Bioanalytical; LC MS MS; Method development validation

Indexed keywords

DISEASES; EXTRACTION; LIQUID CHROMATOGRAPHY; MASS SPECTROMETERS; PLASMA (HUMAN);

ATOVAQUONE; BIOANALYTICAL; HUMAN PLASMAS; LC-MS-MS; LC.MS/MS; METHOD DEVELOPMENT; METHOD VALIDATIONS; METHOD-DEVELOPMENT/VALIDATION; PLASMA EXTRACTIONS; SPECTROMETRIC METHODS;

MASS SPECTROMETRY;

ATOVAQUONE; LAPACHOL;

ARTICLE; CONTROLLED STUDY; DRUG DETERMINATION; DRUG ISOLATION; DRUG STRUCTURE; HEATING; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; LIQUID CHROMATOGRAPHY; NEBULIZER; PLASMA; SENSITIVITY ANALYSIS; STANDARD; SUSPENSION; TANDEM MASS SPECTROMETRY; VALIDITY;

EID: 77951740252     PISSN: 02693879     EISSN: 10990801     Source Type: Journal    
DOI: 10.1002/bmc.1317     Document Type: Article

References (29)

1. Aarnoutse RE, Schapiro JM, Boucher CA, Hekster YA and Burger DM. Therapeutic drug monitoring: an aid to optimising response to antiretroviral drugs? Drugs 2003; 63: 741-753. (Pubitemid 36428444)
2. Bergqvist Y, Funding L, Krysen B, Leek T and Yvell K. Improved validated assay for the determination of proguanil and its metabolites in plasma, whole blood, and urine using solid-phase extraction and high-performance liquid chromatography. Therapeutic Drug Monitoring 1998; 20: 325-330. (Pubitemid 28248854)
3. Bergqvist Y and Hopstadius C. Simultaneous separation of atovaquone, proguanil and its metabolites on a mixed mode high performance liquid chromatographic column. Journal of Chromatography B 2000; 741: 189-193. (Pubitemid 30243209)
4. Chou C-C, Brown MP and Merritt KA. Capillary zone electrophoresis for the determination of atovaquone in serum. Journal of Chromatography B: Biomedical Sciences and Applications 2000; 742: 441-445. (Pubitemid 30331063)
5. DeAngelis DV, Long JD, Kanics LL and Woolley JL. High-performance liquid chromatographic assay for the measurement of atovaquone in plasma. Journal of Chromatography B 1994; 652: 211-219. (Pubitemid 24081328)
6. Dunay IR, Heimesaat, MM, Bushrab FN, Muller RH, Stocker H, Arasteh K, Kurowski, M, Fitzner R, Borner K and Liesenfeld O. Atovaquone maintenance therapy prevents reactivation of toxoplasmic encephalitis in a murine model of reactivated toxoplasmosis. Antimicrobial Agents and Chemotherapy 2004; 48: 4848-4854. (Pubitemid 39577693)
7. Falloon J, Kovacs J, Hughes W, O'Neill D, Polis M, Davey RT, Rogers M, LaFon S, Feuerstein I, Lancaster D et al. A preliminary evaluation of 566C80 for the treatment of pneumocystis pneumonia in patients with the acquired immunodefi ciency syndrome. The New England Journal of Medicine 1991; 325:1534-1538.
8. Freeman CD, Klutman NE, Lamp KC, Dall LH and Strayer AH. Relative bioavailability of atovaquone suspension when administered with an enteral nutrition supplement. The Annals of Pharmacotherapy 1998; 32: 1004-1007.
9. Fry M, Hudson AT, Randall AW and Williams RB, Potent and selective hydroxyl-naphthoquinone inhibitors of mitochondrial electron transport in Eimeria tenella (Apicomplexa: Coccidia). Biochemical Pharmacology 1984; 33: 2115-2122. (Pubitemid 14124930)
10. FDA. Guidance for Industry: Analytical Procedures and Method Validation. US Food and Drug Administration, Drug Evaluation and Research, Rockville, MD, 2000.
11. FDA. Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations. US Food and Drug Administration, Drug Evaluation and Research, Rockville, MD, March 2003a. Available from: www.fda.gov/cder/guidance/5356fnl pdf (accessed 22 February 2009).
12. FDA. Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations. US Food and Drug Administration, Drug Evaluation and Research, Rockville, MD, 2003b. Available at www.fda.gov/cder/guidance/5356fnl (accessed 22February, 2009).
13. Gillotin C, Mamet JP and Veronese L, Lack of a pharmacokinetic interaction between atovaquone and proguanil. European Journal of Clinical Pharmacology, 1999; 55: 311-315. (Pubitemid 29290924)
14. Haile LG and Flaherty JF. Atovaquone: a review. The Annals of Pharmacotherapy, 1993; 27: 1488-1494.
15. Hannan SL, Ridout GA and Jones AE, Determination of the potent antiprotozoal compound atovaquone in plasma using liquid-liquid extraction followed by reverse phase high-performance liquid chromatography with ultraviolet detection. Journal of Chromatography B, 1996; 678: 297-302.
16. Hansson AG, Mitchell S, Jatlow P and Rainey PM. Rapid high-performance liquid chromatographic assay for atovaquone. Journal of Chromatography B 1996; 675: 180-182. (Pubitemid 26036984)
17. Hudson AT, Randall AW, Fry M, Ginger CD, Hill B, Latter VS, McHardy N and Williams RB. Novel anti-malarial hydroxynaphthoquinones with potent broad spectrum anti-protozoal activity. Parasitology 1985; 90: 45-55. (Pubitemid 15151736)
18. Hughes WT. The role of atovaquone tablets in treating Pneumocystis carinii pneumonia. Journal of Acquired Immune Defi ciency Syndromes and Human Retrovirology 1995; 8(3): 247-252.
19. Hughes W T, Gutteridge WE, Latter VS and Pudney M. Effi cacy of a hydroxynaphthoquinone, 566C80, in experimental Pneumocystis carinii pneumonitis. Antimicrobial Agents and Chemotherapy1990; 34: 225-228.
20. Hughes WT, Kennedy W, Shenep JL, Flynn PM, Hetherington SV, Fullen G, Lancaster DJ, Stein DS, Palte S, Rosenbaum D et al.Safety and pharmacokinetics of 566C80, a hydroxynaphthoquinone with anti-Pneumocystis carinii activity: a phase I study in human immunodefi ciency virus (HIV)-infected men. The Journal of Infectious Diseases 1991; 163:843-848.
21. Kappelhoff BS, Crommentuyn KML, Maat MMR, Mulder JW, Huitema ADR and Beijnen JH. Practical guidelines to interpret plasma concentrations of antiretroviral drugs. Practical guidelines to interpret plasma concentrations of antiretroviral drugs. Clinical Pharmacokinetics 2004; 43(13): 845-853.
22. Kovacs JA. Effi cacy of atovaquone in treatment of toxoplasmosis in patients with AIDS. The Lancet 1992; 340(8820): 637-638.
23. Lindegårdh N, Blessborn D and Bergqvist Y. Simultaneous quantitation of the highly lipophilic atovaquone and hydrophilic strong basic proguanil and its metabolites using a new mixed-mode SPE approach and steep-gradient LC. Journal of Chromatographic Science 2005; 43(5): 259-266. (Pubitemid 40937573)
24. Rolan PE, Mercer AJ, Weatherley BC, Holdich T, Meire H, Peck RW, Ridout G and Posner J. Examination of some factors responsible for a foodinduced increase in absorption of atovaquone. British Journal of Clinical Pharmacology 1994; 37: 13-20. (Pubitemid 24204575)
25. Rolan PE, Mercer AJ, Tate E, Benjamin I and Posner J. Disposition of atovaquone in humans. Antimicrobial Agents and Chemotherapy 1997; 41: 1319-1321.
26. Souverain S, Rudaz S and Veuthey JL. Matrix eff ect in LC-ESI-MS and LC-APCI-MS with off -line and on-line extraction procedures. Journal of Chromatography A 2004; 1058(1-2): 61-66. (Pubitemid 39487204)
27. Studenberg SD, Long JD, Woolf JH, Bruner CJ, Wilson D and Woolley JL. A robotics-based liquid chromatographic assay for the measurement of atovaquone in plasma. Journal of Pharmaceutical and Biomedical Analysis 1995; 13: 1383-1393.
28. Thapar MM, Gupta S, Spindler C, Wernsdorfer WH and Björkman A. Pharmacodynamic interactions among atovaquone, proguanil and cycloguanil against Plasmodium falciparum in vitro. Transactions of the Royal Society of Tropical Medicine and Hygiene 2003; 97(3): 331-337. (Pubitemid 39185892)
29. Yeo AET, Edstein MD, Shanks GD and Rieckmann KH. Potentiation of the antimalarial activity of atovaquone by doxycycline against Plasmodium falciparum in vitro. Parasitology Research 1997; 83: 489-491. (Pubitemid 27245117)