Sensitive and precise HPLC method with back-extraction clean-up step for the determination of sildenafil in rat plasma and its application to a pharmacokinetic study

Biomedical Chromatography

Volumn 29, Issue 10, 2015, Pages 1559-1566

  Strach, Beata ^a   Wyska, Elzbieta ^a   Pociecha, Krzysztof ^a   Krupa, Anna ^a   Jachowicz, Renata ^a  

^a JAGIELLONIAN UNIVERSITY MEDICAL COLLEGE   (Poland)

Author keywords

HPLC UV; Pharmacokinetics; Rats; Sample stability; Sildenafil

Indexed keywords

BODY FLUIDS; EXTRACTION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; PHARMACOKINETICS; PLASMA STABILITY; POTASSIUM COMPOUNDS;

BACK EXTRACTION; HPLC METHOD; HPLC-UV; ITS APPLICATIONS; LIQUID-LIQUID EXTRACTION PROCEDURE; PAROXETINE; PHARMACOKINETIC STUDIES; RAT PLASMA; SAMPLE STABILITY; SILDENAFIL;

RATS;

ACETONITRILE; PAROXETINE; POTASSIUM DIHYDROGEN PHOSPHATE; SILDENAFIL;

ACCURACY; ACIDITY; ANALYTIC METHOD; ANIMAL EXPERIMENT; AREA UNDER THE CURVE; ARTICLE; BACK EXTRACTION CLEAN UP; CONTROLLED STUDY; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG HALF LIFE; DRUG STABILITY; DRUG STORAGE; ELIMINATION RATE CONSTANT; FEMALE; FLOW RATE; FREEZE THAWING; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; LIMIT OF DETECTION; LIMIT OF QUANTITATION; LIQUID LIQUID EXTRACTION; MALE; MAXIMUM PLASMA CONCENTRATION; NONHUMAN; PLASMA CONCENTRATION-TIME CURVE; RAT; SENSITIVITY ANALYSIS; SIGNAL NOISE RATIO; SINGLE DRUG DOSE; SOLID PHASE EXTRACTION; STORAGE TEMPERATURE; TIME TO MAXIMUM PLASMA CONCENTRATION; ULTRAVIOLET RADIATION; ANIMAL; BLOOD; CALIBRATION; DEVICES; PROCEDURES; REPRODUCIBILITY; SENSITIVITY AND SPECIFICITY; WISTAR RAT;

ANIMALS; CALIBRATION; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG STABILITY; FEMALE; LIMIT OF DETECTION; LIQUID-LIQUID EXTRACTION; MALE; RATS, WISTAR; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; SILDENAFIL CITRATE; ULTRAVIOLET RAYS;

EID: 84941173069     PISSN: 02693879     EISSN: 10990801     Source Type: Journal    
DOI: 10.1002/bmc.3459     Document Type: Article

References (32)

1. Al-Ghazawi M, Tutunji M and Aburuz S. Simultaneous determination of sildenafil and N-desmethyl sildenafil in human plasma by high-performance liquid chromatography method using electrochemical detection with application to a pharmacokinetic study. Journal of Pharmaceutical and Biomedical Analysis 2007; 43: 613-618.
2. Bae SH, Bae SK and Lee MG. Effect of hepatic CYP inhibitors on the metabolism of sildenafil and formation of its metabolite, N-desmethylsildenafil, in rats in vitro and in vivo. Journal of Pharmacy and Pharmacology 2009; 61: 1637-1642.
3. Bartošová Z, Jirovský D and Horna A. High-performance liquid chromatographic method with amperometric detection employing boron-doped diamoned electrode for the determination of sildenafil, vardenafil and their metabolites in plasma. Journal of Chromatography A 2011; 1218: 7996-8001.
4. Beedimani RS, Kalmath B. Current and emerging uses of phosphodiesterase 5 inhibitors. International Journal of Pharma and Bio Sciences 2014; 5: 530-539.
5. Berzas Nevado JJ, Flores JR, Peñalvo GC and Rodriguez FN. Determination of sildenafil citrate and its main metabolite by sample stacking with polarity switching using micellar electrokinetic chromatography. Journal of Chromatography A 2002a; 953: 279-286.
6. Berzas Nevado JJ, Villaseñor Llerena MJ, Contento Salcedo AM and Rodríguez Flores J. Development of a capillary gas chromatographic method with flame ionisation detection for the simultaneous determination of sildenafil and its N-demethylated metabolite in biological fluids. Journal of Separation Science 2002b; 25: 767-772.
7. Cooper JD, Muihead DC, Taylor JE and Baker PR. Development of an assay for the simultaneous determination of sildenafil (Viagra) and its metabolite (UK-103, 320) using automated sequential trace enrichment of dialysates and high-performance liquid chromatography. Journal of Chromatography B 1997; 701: 87-95.
8. Czerniak R. Gender-based differences in pharmacokinetics in laboratory animal models. International Journal of Toxicology 2001; 20: 161-163.
9. Eerkes A, Addison T and Naidong W. Simultaneous assay of sildenafil and desmethylsildenafil in human plasma using liquid chromatography-tandem mass spectrometry on silica column with aqueous-organic mobile phase. Journal of Chromatography B 2002; 768: 277-284.
10. Gabrielsson J, Weiner D., 2nd edn, Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Applications. Swedish Pharmaceutical Press: Stockholm 1997; 289-309.
11. Gobry V, Bouchard G, Carrupt PA, Testa B and Girault HH. Physicochemical characterization of sildenafil: ionization, lipophilicity behavior, and ionic-partition diagram studied by two-phase titration and electrochemistry. Helvetica Chimica Acta 2000; 83: 1465-1474.
12. Guermouche MH, Bensalah K. Solid phase extraction and liquid chromatographic determination of sildenafil and N-demethylsildenafil in rat serum with basic mobile phase. Journal of Pharmaceutical and Biomedical Analysis 2006; 40: 952-957.
13. Jeong CK, Lee HY, Jang MS, Kim WB and Lee HS. Narrow bore high-performance liquid chromatography for the simultaneous determination of sildenafil and its metabolite UK-103, 320 in human plasma using column switching. Journal of Chromatography B 2001; 752: 141-147.
14. Kim J, Ji H, Kim SJ, Lee HW, Lee SS, Kim DS, Yoo M, Kim WB and Lee HS. Simultaneous determination of sildenafil and its active metabolite UK-103, 320 in human plasma using liquid chromatography-tandem mass spectrometry. Journal of Pharmaceutical and Biomedical Analysis 2003; 32: 317-322.
15. Kruuse C, GuptaS NE, Kruse L and Edvinsson L. Differential vasodilative effects of sildenafil and tadalafil on cerebral arteries. European Journal of Pharmacology 2012; 674: 345-351.
16. Lee M, Min DI. Determination of sildenafil citrate in plasma by high-performance liquid chromatography and a case for the potential interaction of grapefruit juice with sildenafil citrate. Therapeutic Drug Monitoring 2001; 23: 21-26.
17. Nichols DJ, Muirhead GJ and Harness JA. Pharmacokinetics of sildenafil after single oral doses in healthy male subjects: absolute bioavailability, food effects and dose proportionality. British Journal of Clinical Pharmacology 2002; 53(Suppl 1): 5S-12S.
18. Pistos C, Papoutsis I, Dona A, Stefanidou M, Athanaselis S, Maravelias C and Spiliopoulou C. Off-line HPLC method combined to LC-MS for the determination of sildenafil and its active metabolite in post-mortem human blood according to confirmation criteria. Forensic Science International 2008; 178: 192-198.
19. Rust KY, Wilkens H, Kaiser R, Bregel D, Wilske J and Kraemer T. Detection and validated quantification of the phosphodiesterase type 5 inhibitors sildenafil, vardenafil, tadalafil, and 2 of their metabolites in human blood plasma by LC-MS/MS-application to forensic and therapeutic drug monitoring cases. Therapeutic Drug Monitoring 2012; 34: 729-735.
20. Sheu MT, Wu AB, Yeah GC, Hsia A and Ho HO. Development of a liquid chromatographic method for bioanalytical applications with sildenafil. Journal of Chromatography B 2003; 791: 255-262.
21. Socała K, Nieoczym D, Wyska E, Poleszak E and Wlaź P. Sildenafil, a phosphodiesterase type 5 inhibitor, enhances the antidepressant activity of amitriptyline but not desipramine, in the forced swim test in mice. Journal of Neural Transmission 2012a; 119: 645-652.
22. Socała K, Nieoczym D, Wyska E, Poleszak E and Wlaź P. Sildenafil, a phosphodiesterase type 5 inhibitor, enhances the activity of two atypical antidepressant drugs, mianserin and tianeptine, in the forced swim test in mice. Progress in Neuro-Psychopharmacology and Biological Psychiatry 2012b; 38: 121-126.
23. Terry AV Jr, Callahan PM, Hall B and Webster SJ. Alzheimer's disease and age-related memory decline (preclinical). Pharmacology, Biochemistry and Behavior 2011; 99: 190-210.
24. Tracqui A, Ludes B. HPLC-MS for the determination of sildenafil citrate (Viagra) in biological fluids. Application to the salivary excretion of sildenafil after oral intake. Journal of Analytical Toxicology 2003; 27: 88-94.
25. US DHHS, FDA and CDER. Guidance for Industry: Bioanalytical Method Validation. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research and Center for Veterinary Medicine: Rockville, MD, 2013.
26. Uthayathas S, Karuppagounder SS, Thrash BM, Parameshwaran K, Suppiramaniam V and Dhanasekaran M. Versatile effects of sildenafil: recent pharmacological applications. Pharmacological Reports 2007; 59: 150-163.
27. Wallace TL, Ballard TM, Pouzet B, Riedel WJ and Wettstein JG. Drug targets for cognitive enhancement in neuropsychiatric disorders. Pharmacology, Biochemistry and Behavior 2011; 99: 130-145.
28. Wang Y, Wang J, Cui Y, Fawcett JP and Gu J. Liquid chromatographic-tandem mass spectrometric method for the quantitation of sildenafil in human plasma. Journal of Chromatography B 2005; 828: 118-121.
29. Wardle A, Tulloh R. Update on pulmonary arterial hypertension in children: management strategies and clinical utility of sildenafil. Pediatric Health, Medicine and Therapeutics 2012; 3: 59-67.
30. Weinmann W, Bohnert M, Wiedemann A, Rens M, Lehmann N and Pollak S. Post-mortem detection and identification of sildenafil (Viagra) and its metabolites by LC/MS and LC/MS/MS. International Journal of Legal Medicine 2001; 114: 252-258.
31. Xiao C, Tang M, Li J, Yin C, Xiang G and Xu L. Determination of sildenafil, vardenafil and aidenafil in human plasma by dispersive liquid-liquid microextraction-back extraction based on ionic liquid and high performance liquid chromatography-ultraviolet detection. Journal of Chromatography B 2013; 931: 11-116.
32. Yokoyama Y, Tomatsuri M, Hayashi H, Hirai K, Ono Y, Yamada Y, Todoroki K, Toyo'oka T, Yamada H and Itoh K. Simultaneous microdetermination of bosentan, ambrisentan, sildenafil, and tadalafil in plasma using liquid chromatography/tandem mass spectrometry for pediatric patients with pulmonary arterial hypertension. Journal of Pharmaceutical and Biomedical Analysis 2014; 89: 227-232.