Comparison of the quantitative performances and measurement uncertainty estimates obtained during method validation versus routine applications of a novel hydrophilic interaction chromatography method for the determination of cidofovir in human plasma

Journal of Pharmaceutical and Biomedical Analysis

Volumn 57, Issue 1, 2012, Pages 153-165

  Lecomte, F ^a   Hubert, C ^a   Demarche, S ^a   De Bleye, C ^a   Dispas, A ^a   Jost, M ^c   Frankenne, F ^c   Ceccato, A ^b   Rozet, E ^a   Hubert, Ph ^a  

^a UNIVERSITY OF LIÈGE   (Belgium)

^b Odyssea Pharma ^*  (Belgium)

^c Mithra Pharmaceuticals   (Belgium)

Author keywords

Cidofovir bioanalysis; HILIC; Routine assessment; Uncertainty; Validation

Indexed keywords

ACETONITRILE; AMMONIUM HYDROGEN CARBONATE; CARBONIC ACID DERIVATIVE; CIDOFOVIR; UNCLASSIFIED DRUG;

ARTICLE; CONCENTRATION (PARAMETERS); COST CONTROL; HUMAN; HYDROPHILIC INTERACTION CHROMATOGRAPHY; INTERMETHOD COMPARISON; MEASUREMENT ERROR; PH; PRIORITY JOURNAL; PROBABILITY; PROCESS OPTIMIZATION; QUALITY CONTROL; SOLID PHASE EXTRACTION; VALIDATION PROCESS;

ANTIVIRAL AGENTS; CYTOSINE; HUMANS; PHOSPHONIC ACIDS; REFERENCE STANDARDS; UNCERTAINTY;

EID: 80054040467     PISSN: 07317085     EISSN: 1873264X     Source Type: Journal    
DOI: 10.1016/j.jpba.2011.08.040     Document Type: Article

References (55)

1. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Guidance for Industry: Bioanalytical Method Validation, May 2001.
2. JCGM 100:2008, Evaluation of measurement data-Guide to the expression of uncertainty in measurement (GUM), 2008, (Accessed on March 16th 2011). http://www.bipm.org/utils/common/documents/jcgm/JCGM_100_2008_F.pdf.
3. Hund E., Massart D.L., Smeyers-Verbeke J. Operational definitions of uncertainty. Trends Anal. Chem. 2001, 20:394-406.
4. EURACHEM/CITAC Guide, Quantifying Uncertainty in Analytical Measurement 2000, Eurachem, Berlin. second ed. S.L.R. Ellison, M. Rösslein, A. Williams (Eds.).
5. Fuentes-Arderiu X. Uncertainty of measurement in clinical laboratory sciences. Clin. Chem. 2000, 46:1437-1438.
6. Gonzalez A.G., Herrador M.A. A practical guide to analytical method validation, including measurement uncertainty and accuracy profiles. Trends Anal. Chem. 2007, 26:227-238.
7. Rozet E., Marini R.D., Ziemons E., Boulanger B., Hubert Ph. Advances in validation, risk and uncertainty assessment of bioanalytical methods. J. Pharm. Biomed. Anal. 2011, 55:848-858. http://hdl.handle.net/2268/81649.
8. Peters F.T., Drummer O.H., Musshoff F. Validation of new method. Forensic Sci. Int. 2007, 165:216-224.
9. Rozet E., Marini R.D., Ziemons E., Hubert Ph., Dewé W., Rudaz S., Boulanger B. Total error and uncertainty: friends or foes?. Trends Anal. Chem. 2011, 30:797-806. http://hdl.handle.net/2268/81653.
10. Maroto A., Boqué R., Riu J., Xavier Rius F. Evaluating uncertainty in routine analysis. Trends Anal. Chem. 1999, 18:577-584.
11. Hund E., Massart D.L., Smeyers-Verbeke J. Comparison of different approaches to estimate the uncertainty of a liquid chromatographic assay. Anal. Chim. Acta 2003, 480:39-52.
12. Hayden F.G. Goodman and Gilman's the Pharmacological Basis of Therapeutics 1996, 1191-1223. McGraw Hill, New York. J.G. Hardman, L.E. Limbird (Eds.).
13. Santoyo S., de Jalon E.G., Campanero M.A., Ygartua P. Determination of cidofovir in both skin layers and percutaneous penetration samples by HPLC. J. Pharm. Biomed. Anal. 2002, 29:819-826.
14. Marrie T.J., Touchie C., Johnston B.L., Forward K.R., Slayter K.L., Lee S., Hoffman P. Melmon and Morrelli's clinical pharmacology: basic principles in therapeutics 2000, 873-1002. McGraw-Hill, New York. S. Carruthers, B. Hoffman, K. Melmon, D. Nierenberg (Eds.).
15. Cundy K.C., Betty B.G., Flaherty J., Fisher P.E., Polis M.A., Wachsman M., Lietman P.S., Lalezari J.P., Hitchcock M.J.M., Jaffe H.S. Clinical pharmacokinetics of cidofovir in human immunodeficiency virus-infected patients. Antimicrob. Agents Chemother. 1995, 39:1247-1252.
16. Eisenberg E.J., Cundy K.C. High-performance liquid chromatographic determination of cytosine-containing compounds by precolumn fluorescence derivatization with phenacyl bromide: application to antiviral nucleosides and nucléotides. J. Chromatogr. B 1996, 679:119-127.
17. Ba B.B., Saux M.-C. Separation methods for antiviral phosphorous-containing drugs. J. Chromatogr. B 2001, 764:349-362.
18. Aronson J.K. Meyler's Side Effects of Drugs: the International Encyclopedia of Adverse Drug Reactions and Interactions 2006, 771-773. Elsevier, Amsterdam. J.K. Aronson (Ed.).
19. Snoeck R., Noel J.-C., Muller C., Declercq E., Bossens M. Cidofovir, a new approach for the treatment of cervix intraepithelial neoplasia grade III (CIN III). J. Med. Virol. 2000, 60:205-209.
20. Oliyai R., Lee W.A., Visor G.C., Yuan L.-C. Enhanced chemical stability of the intracellular prodrug, 1-[((S)-2-hydroxy-2-oxo-1,4,2-dioxaphosphorinan-5-yl)methyl]cytosine, relative to its parent compound, cidofovir. Int. J. Pharm. 1999, 179:257-265.
21. Alpert A.J. Hydrophilic-interaction chromatography for the separation of peptides, nucleic acids and other polar compounds. J. Chromatogr. 1990, 499:177-196.
22. McCalley D.V. Is hydrophilic interaction chromatography with silica columns a viable alternative to reversed-phase liquid chromatography for the analysis of ionisable compounds?. J. Chromatogr. A 2007, 1171:46-55.
23. McCalley D.V. Study of the selectivity, retention mechanisms and performance of alternative silica-based stationary phases for separation of ionised solutes in hydrophilic interaction chromatography. J. Chromatogr. A 2010, 1217:3408-3417.
24. Ikegami T., Tomomatsu K., Takubo H., Horie K., Tanaka N. Separation efficiencies in hydrophilic interaction chromatography. J. Chromatogr. A 2008, 1184:474-503.
25. Hemström P., Irgum K. Hydrophilic interaction chromatography. J. Sep. Sci. 2006, 29:1784-1821.
26. Olsen B.A. Hydrophilic interaction chromatography using amino and silica columns for the determination of polar pharmaceuticals and impurities. J. Chromatogr. A 2001, 913:113-122.
27. Brown S.D., White C.A., Bartlett M.G. Hydrophilic interaction liquid chromatography/electrospray mass spectrometry determination of acyclovir in pregnant rat plasma and tissues. Rapid Commun. Mass Spectrom. 2002, 16:1871-1876.
28. Kovalova L., McArdell C.S., Hollender J. Challenge of high polarity and low concentrations in analysis of cytostatics and metabolites in wastewater by hydrophilic interaction chromatography/tandem mass spectrometry. J. Chromatogr. A 2009, 1216:1100-1108.
29. Marrubini G., Enrique B., Mendoza C., Massolini G. Separation of purine and pyrimidine bases and nucleosides by hydrophilic interaction chromatography. J. Sep. Sci. 2010, 33:803-816.
30. Breddemann A., Hsien L., Tot E., Läer S. Quantification of cidofovir in human serum by LC-MS/MS for children. J. Chromatogr. B 2008, 861:1-9.
31. Momper J.D., Zhang S., Randhawa P.S., Shapiro R., Schonder K.S., Venkataramanan R. Determination of cidofovir in human plasma after low dose drug administration using high-performance liquid chromatography-tandem mass spectrometry. J. Pharm. Biomed. Anal. 2010, 53:1015-1021.
32. Viswanathan C.T., Bansal S., Booth B., DeStefano A.J., Rose M.J., Sailstad J., Shah V.P., Skelly J.P., Swann P.G., Weiner R. Workshop/conference report-quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays. AAPS J. 2007, 9:E30-E42.
33. Hubert Ph., Nguyen-Huu J.-J., Boulanger B., Chapuzet E., Chiap P., Cohen N., Compagnon P.-A., Dewe W., Feinberg M., Lallier M., Laurentie M., Mercier N., Muzard G., Nivet C., Valat L. Harmonization of strategies for the validation of quantitative analytical procedures: SFSTP proposal-Part I. J. Pharm. Biomed. Anal. 2004, 36:579-589. http://hdl.handle.net/2268/6169.
34. Hubert Ph., Nguyen-Huu J.J., Boulanger B., Chapuzet E., Chiap P., Cohen N., Compagnon P.A., Dewé W., Feinberg M., Lallier M., Laurentie M., Mercier N., Muzard G., Nivet C., Valat L., Rozet E. Harmonization of strategies for the validation of quantitative analytical procedures: SFSTP proposal-Part II. J. Pharm. Biomed. Anal. 2007, 45:70-81. http://hdl.handle.net/2268/6170.
35. Hubert Ph., Nguyen-Huu J.J., Boulanger B., Chapuzet E., Cohen N., Compagnon P.-A., Dewé W., Feinberg M., Laurentie M., Mercier N., Muzard G., Valat L., Rozet E. Harmonization of strategies for the validation of quantitative analytical procedures: SFSTP proposal-Part III. J. Pharm. Biomed. Anal. 2007, 45:82-96. http://hdl.handle.net/2268/41022.
36. Feinberg M., Boulanger B., Dewé W., Hubert Ph. New advances in method validation and measurement uncertainty aimed at improving the quality of chemical data. Anal. Bioanal. Chem. 2004, 380:502-514. http://hdl.handle.net/2268/6186.
37. Blanchard J. Evaluation of the relative efficacy of various techniques for deproteinizing plasma samples prior to high-performance liquid chromatographic analysis. J. Chromatogr. 1981, 226:455-460.
38. Polson C., Sarkar P., Incledon B., Raguvaran V., Grant R. Optimization of protein precipitation based upon effectiveness of protein removal and ionization effect in liquid chromatography-tandem mass spectrometry. J. Chromatogr. B 2003, 785:263-275.
39. Takegawa Y., Deguchi K., Ito H., Keira T., Nakagawa H., Nishimura S.-I. Simple separation of isomeric sialylated N-glycopeptides by a zwitterionic type of hydrophilic interaction chromatography. J. Sep. Sci. 2006, 29:2533-2540.
40. Guo Y., Srinivasan S., Gaiki S. Investigating the effect of chromatographic conditions on retention of organic acids in hydrophilic interaction chromatography using a design of experiment. Chromatographia 2007, 66:223-229.
41. Mee R.W. β-Expectation and β-content tolerance limits for balanced one-way ANOVA random model. Technometrics 1984, 26:251-254.
42. Matuszewski B.K., Constanzer M.L., Chavez-Eng C.M. Strategies for the assessment of matrix effect in quantitative bioanalytical methods based on HPLC-MS/MS. Anal. Chem. 2003, 75:3019-3030.
43. Hubert Ph., Chiap P., Crommen J., Boulanger B., Chapuzet E., Mercier N., Bervoas-Martin S., Chevalier P., Grandjean D., Lagorce P., Lallier M., Laparra M.C., Laurentie M., Nivet J.C. The SFSTP guide on the validation of chromatographic methods for drug bioanalysis: from the Washington Conference to the laboratory. Anal. Chim. Acta 1999, 391:135-148. http://hdl.handle.net/2268/5926.
44. Baumann K., Wätzig H. Appropriate calibration functions for capillary electrophoresis II. Heteroscedasticity and its consequences. J. Chromatogr. A 1995, 700:9-20.
45. ISO 5725-1 Application of the Statistics-Accuracy (Trueness and Precision) of the Results and Methods of Measurement-Part 1: General Principles and Definitions 1994, International Organization for Standardization (ISO), Geneva, Switzerland.
46. Rozet E., Ceccato A., Hubert C., Ziemons E., Oprean R., Rudaz S., Boulanger B., Hubert Ph. Analysis of recent pharmaceutical regulatory documents on analytical method validation. J. Chromatogr. A 2007, 1158:111-125. http://hdl.handle.net/2268/3646.
47. Hubert Ph., Nguyen-Huu J.-J., Boulanger B., Chapuzet E., Cohen N., Compagnon P.-A., Dewé W., Feinberg M., Laurentie M., Mercier N., Muzard G., Valat L., Rozet E. Harmonization of strategies for the validation of quantitative analytical procedures: a SFSTP proposal: Part IV. Examples of application. J. Pharm. Biomed. Anal. 2008, 48:760-771. http://hdl.handle.net/2268/6171.
48. Marini R.D., Servais A.-C., Rozet E., Chiap P., Boulanger B., Rudaz S., Crommen J., Hubert Ph., Fillet M. Nonaqueous capillary electrophoresis method for the enantiomeric purity determination of S-timolol using heptakis(2,3-di-O-methyl-6-O-sulfo)-β-cyclodextrin: Validation using the accuracy profile strategy and estimation of uncertainty. J. Chromatogr. A 2006, 1120:102-111. http://hdl.handle.net/2268/9010.
49. Schepers U., Ermer J., Preu L., Wätzig H. Wide concentration range investigation of recovery, precision and error structure in HPLC. J. Chromatogr. B 2004, 810:111-118.
50. Horwitz W. Evaluation of analytical methods used for regulation of foods and drugs. Anal. Chem. 1982, 54:67A-76A.
51. Horwitz W., Albert R. Performance characteristics of methods of analysis used for regulatory purposes. I. Drug dosage forms. D. High pressure liquid chromatographic methods. J. AOAC Int. 1985, 68:191-198.
52. Horwitz W., Albert R. Reliability of the determinations of polychlorinated contaminants (biphenyls, dioxins, furans). J. AOAC Int. 1996, 79:589-621.
53. Marini R.D., Chiap P., Boulanger B., Rudaz S., Rozet E., Crommen J., Hubert Ph. LC method for the determination of R-timolol in S-timolol maleate: validation of its ability to quantify and uncertainty assessment. Talanta 2006, 68:1166-1175. http://hdl.handle.net/2268/9013.
54. Eurachem/Citac Guide, Quantifying the uncertainty in analytical measurement, second ed., 2000.
55. EA-4/16, EA Guidelines on the Expression of Uncertainty in Quantitative Testing, 2004, http://www.european-accreditation.org/.