Validation of high-performance liquid chromatography methods for determination of zidovudine, stavudine, lamivudine and indinavir in human plasma

Farmacia Hospitalaria

Volumn 31, Issue 4, 2007, Pages 243-247

  Tarinas, Alicia ^a   Tapanes R D ^a   Ferrer, G ^a   Perez J ^a  

^a INSTITUTO DE MEDICINA TROPICAL PEDRO KOURÍ   (Cuba)

Author keywords

HPLC; Indinavir; Lamivudine; Liquid chromatography; Solid phase extraction; Stavudine; Validation; Zidovudine

Indexed keywords

INDINAVIR; LAMIVUDINE; STAVUDINE; ZIDOVUDINE;

ACCURACY; ARTICLE; DRUG BLOOD LEVEL; DRUG DETERMINATION; DRUG FORMULATION; DRUG ISOLATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; ULTRAVIOLET RADIATION; VALIDATION STUDY;

EID: 36349027587     PISSN: 11306343     EISSN: None     Source Type: Journal    
DOI: 10.1016/S1130-6343(07)75381-3     Document Type: Article

References (33)

1. Shah VP, Midha KK, Dighe S, Mc Gilveray IJ, Skelly JP, Yacobi A, et al. Analytical methods validation: Bioavailability, bioequivalence and pharmacokinetic studies. Int J Pharm 1992; 82: 1-7.
2. Kakuda TN, Page LM, Anderson PL, Henry K, Schacker TW, Rhame FS, et al. Pharmacological basis for concentration-controlled therapy with zidovudine, lamivudine and indinavir. Antimicrob Agents Chemother 2001: 236-42.
3. Pérez D, Pérez J, Orta M, Trujillo A, Gonzalez A. Two year follow up of patients treated with generis antiretrovirals. (CD-ROM) International Proceedings XV International AIDS Conference; July 2004: 11-16; Bangkok, Thailand: MEDIMOND S.r.l.; 2004.
4. Langtry HD, Campoli-Richards DM. Zidovudine: A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy. Drugs 1989; 37: 408-50.
5. Macnab KA. Erratic zidovudine bioavailability in HIV seropositive patients. J Antimicrob Chemother 1993; 31: 421-8.
6. Rana KZ, Dudley MN. Clinical Pharmacokinetics of stavudine. Clin Pharmacokinet 1997; 33 (4): 276-84.
7. Johnson MA, Moore KHP, Yuen GJ, Bye A, Pakes GE. Clinical pharmacokinetics of lamivudine. Clin Pharmacokinet 1999; 36 (1): 41-66.
8. Poirier JM, Robidou P, Jaillon P. Determination of indinavir in plasma by solid-phase extraction and column liquid chromatography. Ther Drug Monit 1999; 21 (4).
9. Gulick RM, Mellors JW, Havlir D, Eron JJ, González C, McMahon D, et al. Treatment with indinavir, zidovudine, and lamivudine in adults with human immunodeficiency virus infection and prior antiretroviral therapy. N Engl J Med 1997; 337: 734-9.
10. Hammer SM, Squires KE, Hughes MD, Grimes JM, Demeter LM, Currier JS, et al. A controlled trial of two nucleoside analogues plus indinavir in persons with HIV and CD4 cell counts of 200 per cubic millimeter or less. N Engl J Med 1997; 337: 725-33.
11. Good SS, Reynolds DJ, de Mirande P. Simultaneous quantification of zidovudine and its glucuronide in serum by high-performance liquid chromatography. J Chromatogr 1988; 431: 123-33.
12. Zhou XJ, Sommadossi JP. Rapid quantitation of (-)-2′-deoxy- 3′-thiacytidine in human serum by HPLC with ultraviolet detection. J Chromatogr B 1997; 691: 417-24.
13. Harker AJ, Evans GL, Hawley AE, Morris DM. HPLC assay for 2′deoxy-3′-thiacytidine in human serum. J Chromatogr B, 1994; 657: 227-32.
14. Fan B, Stewart JT. Determination of zidovudine/lamivudine/nevirapine in human plasma using ion-pair HPLC. J Pharm Biomed Anal 2002; 28: 903-8.
15. Morris DM, Selinger K. Determination of 2′-deoxy-3′- thiacytidine (3TC) in human urine by liquid chromatography, direct injection with column switching. J Pharm Biomed Anal 1994; 12: 255-64.
16. Verweij-van Vissen CPWGM, Aarnoutse RE, Burger DM. Simultaneous determination of the HIV nucleoside analogue reverse transcriptase inhibitors lamivudine, didanosine, stavudine, zidovudine and abacavir in human plasma by reversed phase HPLC. J Chromatogr B 2005; 816: 121-9.
17. Woolf E, Au T, Haddix H, Mattuszewski B. Determination of L-735,524, an human immunodeficiency virus protease inhibitor in human plasma and urine via HPLC with column switching. J Chromatogr A 1995; 692: 45-52.
18. Hugen PWH, Verweij-van Wissen CPWGM, Burger DM, Wuis EW, Koopsmans PP, Hekster YA. Simultaneous determination of the HIV-protease inhibitors indinavir, nelfinavir, saquinavir and ritonavir in human plasma by reversed-phase HPLC. J Chromatogr B 1999; 727: 139-49.
19. Balani SK, Woolf EJ, Hoagland VL, Sturgill MG, Deutsch PJ, Yeh KC, et al. Disposition of indinavir, a potent HIV-1 protease inhibitor, after an oral dose in humans. Drug Metab Dispos 1996; 24 (12).
20. Burger DM, Rosing H, van Gijn R, Meenhorst PL, van Tellingen O, Beijnem JH. Determination of stavudine, a new antiretroviral agent, in human plasma by reversed-phase HPLC with UV detection. J Chromatogr 1992; 584: 239-47.
21. Jayewardene AL, Zhu F, Aweeka FT, Gambertoglio JG. Simple HPLC determination of the protease inhibitor indinavir in human plasma. J Chromatogr B 1998; 707: 203-11.
22. Moyer TP, Temesgen Z, Enger R, Estes L, Charlson J, Oliver L, et al. Drug monitoring of antiretroviral therapy for HIV-1 infection: Method validation and Results of a Pilot study. Clin Chem 1999; 45 (9): 1465-76.
23. Marchei E, Valvo L, Pacifici R, Pellegrini M, Tossini G, Zuccaro P. Simultaneous determination of zidovudine and nevirapine in human plasma by RP-LC. J Pharm Biomed Anal 2002; 29: 1081-8.
24. Schrive I, Plasse JC. Quantification of zidovudine and one of its metabolites in plasma and urine by solid-phase extraction and high-performance liquid chromatography. J Chromatogr B Biomed Appl 1994; 657 (1): 233-7.
25. Alnouti Y, White CA, Bartlett MG. Simultaneous determination of zidovudine and lamivudine from rat plasma, amniotic fluid and tissues by HPLC. Biomed Chromatogr 2004; 18 (9): 641-7.
26. Estrela R de C, Salvadori MC, Suarez-Kurtz G. A rapid and sensitive method for simultaneous determination of lamivudine and zidovudine in human serum by on-line solid-phase extraction coupled to liquid chromatography/tandem mass spectrometry detection. Rapid Commun Mass Spectrom 2004; 18 (10): 1147-55.
27. Raices RS, Salvadori MC, Estrela R de C, de Aquino Neto FR, Suarez-Kurtz G. Determination of stavudine in human serum by on-line solid-phase extraction coupled to high-performance liquid chromatography with electrospray ionization tandem mass spectrometry: Application to a bioequivalence study. Rapid Commun Mass Spectrom 2003; 17(14): 1611-8.
28. Alnouti Y, White CA, Bartlett MG. Determination of lamivudine in plasma, amniotic fluid, and rat tissues by liquid chromatography. J Chromatogr B Analyt Technol Biomed Life Sci 2004; 803 (2): 279-84.
29. Nadal T, Ortuno J, Pascual JA. Rapid and sensitive determination of zidovudine and zidovudine glucuronide in human plasma by ion-pair high-performance liquid chromatography. J Chromatogr A 1996; 721 (1): 127-37.
30. Bahrami G, Mirzaeei S, Kiani A, Mohammadi B. High-performance liquid chromatographic determination of lamivudine in human serum using liquid-liquid extraction; application to pharmacokinetic studies. J Chromatogr B Analyt Technol Biomed Life Sci 2005; 823 (2): 213-7.
31. Zheng JJ, Wu ST, Emm TA. High-performance liquid chromatographic assay for the determination of 2′-deoxy-3′-thiacytidine (lamivudine) in human plasma. J Chromatogr B Biomed Sci Appl 2001; 761 (2): 195-201.
32. Foisy ML, Sommadossi JP. Rapid quantitation of indinavir in human plasma by high performance liquid chromatography with ultra violet detection. J Chromatogr B Biomed Sci Appl 1999; 721: 239-47.
33. Notari S, Bocedi A, Ippolito G, Narciso P, Pucillo LP, Tossini G, et al. Simultaneous determination of 16 anti-HIV drugs in human plasma by high-performance liquid chromatography. J Chromatogr B 2006; 831: 258-66.