Biovalidation of an SPE-HPLC-UV-fluorescence method for the determination of Valsartan and its metabolite valeryl-4-hydroxy-valsartan in human plasma

Journal of Separation Science

Volumn 30, Issue 14, 2007, Pages 2231-2240

  Iriarte, Gorka ^a   Ferreirós, Nerea ^a   Ibarrondo, Izaskun ^a   Alonso, Rosa Maria ^a   Maguregui, Miren Itxaso ^a   Jimenez, Rosa Maria ^a  

^a UNIVERSITY OF THE BASQUE COUNTRY UPV EHU   (Spain)

Author keywords

Biovalidation; HPLC; Human plasma; Valeryl 4 hydroxy valsartan; Valsartan

Indexed keywords

ANTIHYPERTENSIVE TREATMENT; BIOVALIDATION; VALSARTAN;

FLUOROMETERS; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; METABOLITES; PHOTOMETRY; SEPARATION;

PLASMA (HUMAN);

ACARBOSE; ACECLOFENAC; ACETYLSALICYLIC ACID; ALLOPURINOL; ANTIHYPERTENSIVE AGENT; ATORVASTATIN; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; CANDESARTAN; CARDURAN NEO; CHLORTALIDONE; CO VALS 160; DAONILS; DICLOFENAC; DIHYDROPYRIDINE; DIHYDROPYRIDINE DERIVATIVE; DIOVAN 160; DIOVAN 80; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; DIURETIC AGENT; DOXAZOSIN; DRUG METABOLITE; GLIBENCLAMIDE; GLIPENTIDE; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; NONSTEROID ANTIINFLAMMATORY AGENT; PANTOPRAZOLE; PHOSPHATE; RALOXIFENE; RETINOL PALMITATE; SALMETEROL; SIMVASTATIN; UNCLASSIFIED DRUG; UNINDEXED DRUG; VALERYL 4 HYDROXYVALSARTAN; VALS 80; VALSARTAN; ZOLMITRIPTAN; ZOMIG FLAS;

ADULT; AGED; ANALYTIC METHOD; ARTICLE; BLOOD SAMPLING; CLINICAL ARTICLE; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG INDUSTRY; DRUG STRUCTURE; EXPERIMENTAL DESIGN; FEMALE; FLOW RATE; FLUORESCENCE; FLUOROMETRY; FOOD AND DRUG ADMINISTRATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HYPERTENSION; MALE; MAXIMUM PLASMA CONCENTRATION; PHOTOMETRY; PRIORITY JOURNAL; SOLID PHASE EXTRACTION; TIME TO MAXIMUM PLASMA CONCENTRATION; ULTRAVIOLET RADIATION; VALIDATION PROCESS;

AGED; ANTIHYPERTENSIVE AGENTS; BLOOD CHEMICAL ANALYSIS; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; FEMALE; HUMANS; MALE; MIDDLE AGED; REFERENCE STANDARDS; SOLID PHASE EXTRACTION; SPECTROPHOTOMETRY, ULTRAVIOLET; TETRAZOLES; VALINE;

EID: 34848830402     PISSN: 16159306     EISSN: 16159314     Source Type: Journal    
DOI: 10.1002/jssc.200700033     Document Type: Article

References (35)

1. Flesch, G., Muller, P. H., Lloyd, P., Eur. J. Clin. Pharmacol. 1997, 52, 115-120.
2. Criscione, L., Bradley, W. A., Buhlmayer, P., Whitebread, S., Glazer, R., Lloyd, P., Mueller, P., De Gasparo, M., Cardiovasc. Drug Rev. 1995, 13, 230-250.
3. Oparil, S., Dyke, S., Harris, F., Kief, J., Jamaes, D., Hester, A., Fitzsimmons, S., Clin. Ther. 1996, 18, 797-810.
4. Markham, A., Goa, K. L., Drugs 1997, 54, 299-311.
5. Waldmeier, F., Flesch, G., Müller, P., Winkler, T., Kriemler, H. P., Bühlmayer, P., De Gasparo, M., Xenobiotica 1997, 27, 59-71.
6. Zhang, J., Chen, S., Gu, T., Lu, X., Hu, Y., Shanghai Dier Yike Daxue Xuebao 2004, 24, 133-135, 142.
7. Tatar, S., Saglik, S., J. Pharm. Biomed. Anal. 2002, 30, 371-375.
8. Borovkov, N. N., Sidirova, N. V., Klin. Med. (Mosk.) 2002, 80, 19-21.
9. Erk, N., Anal. Lett. 2002, 35, 283-302.
10. Satana, E., Altinay, S., Gunden-Goger, N., Ozkan, S. A., Senturk, Z., J. Pharm. Biomed. Anal. 2001, 25, 1009-1013.
11. Carlucci, G., Di Carlo, V., Mazzeo, P., Anal. Lett. 2000, 33, 2491-2500.
12. Gonzalez, L., Alonso, R. M., Jiménez, R. M., Chromatographia 2000, 52, 735-740.
13. Francotte, E., Davatz, A., Richert, P., J. Chromatogr. B 1996, 686, 77-83.
14. Brunner, L. A., Powell, M. L., Degen, P., Flesch, G., Lab. Robotics Automat. 1994, 6), 171-179.
15. Daneshtalab, N., Lewanczuk, R. Z., Jamali, F., J. Chromatogr. B 2002, 766, 345-349.
16. Xu, Y., Cao, W., Lin, X., Ling, S., Zhongguo Yaolixue Tongbao 2002, 18, 586-588.
17. Cagigal, E., Gonzalez, L., Alonso, R. M., Jimenez, R. M., Talanta 2001, 54, 1121-1133.
18. Li, Y., Zhao, Z., Chen, X., Wang, J., Guo, J., Xiao, F., Yaowu Fenxi Zazhi 2000, 20, 404-406.
19. Sioufi, A., Marfil, F., Godbillon, J., J. Liq. Chromatogr. 1994, 17, 2179-2186.
20. Maurer, H. H., Kraemer, T., Arlt, J. W., Ther. Drug Monit. 1998, 20, 706-713.
21. Hillaert, S., De Beer, T. R. M., De Beer, J. O., Van den Bossche, W., J. Chromatogr. A 2003, 984, 135-146.
22. Hillaert, S., Van den Bossche, W., J. Pharm. Biomed. Anal. 2003, 31, 329-339.
23. Erdal, D., Bengi, U., Ozkan, S. A., Anal. Lett. 2004, 37, 679-693.
24. Abou Shady, H. A., Moussa, B. A., Farag, A. E., Mahrouse, M. A., Bull. Fac. Pharm. (Cairo University) 2003, 41, 27-46.
25. Iriarte, G., Ferreirós, N., Ibarrondo, I., Alonso, R. M., Maguregi, M. I., Gonzalez, L., Jiménez, R. M., J. Sep. Sci. 2006, 29, 2265-2283.
26. Gonzalez, L., Lopez, J. A., Alonso, R. M., Jimenez, R. M., J. Chromatogr. A 2002, 949, 49-60.
27. Miyabayashi, T., Okuda, T., Motohashi, M., Izawa, K., Yashiki, T., J. Chromatogr. B 1996, 677, 123-132.
28. Guidance for Industry: Bioanalytical Method Validation, US Department of Health and Human Services, Food and Drug Administration, CDER, Rockville 2001.
29. Shah, V. P., Midha, K. K., Dighe, S., McGilveray, I. J., Skelly, J. P., Yacobi, A., Layloff, T., Viswanathan, C. T., Cook, C. E., McDowall, R. D., Eur. J. Drug Metab. Pharmacokin. 1991, 16, 249-255.
30. Goa, K. L., Wagstaff, A. J., Drugs 1996, 51, 820-845.
31. Gillis, J. C., Markham, A., Drugs 1997, 54, 885-902.
32. Markham, A., Goa, K. L., Drugs 1997, 54, 299-311.
33. McClellan, K. J., Goa, K. L., Drugs 1998, 56, 847-869.
34. Validation of Analytical Procedures Q2A. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, London 1994.
35. Validation of Analytical Procedures: Methodology Q2B, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Consensus Guideline, London 1996.