181
Views
15
CrossRef citations to date
0
Altmetric
Original Articles

The Role of the Robustness/Ruggedness and Inertia Studies in Research and Development of Analytical Processes

, &
Pages 57-69 | Received 27 Mar 2001, Accepted 05 Nov 2001, Published online: 12 Jan 2007

REFERENCES

  • Valcárcel , M. and Ríos , A. 2000 . A general approach to validation in analytical chemistry . Quim. Anal. , 19 : 95 – 101 .
  • ISO 9000 . 2000 . Quality Management System. Fundamentals and Vocabulary , Geneva : ISO .
  • The United States Pharmacopeia USP XXIII . 1995 . Validation of Compendial Method , Rockville : United States Pharmacopeia Convention .
  • EURACHEM-EAL G14 1997 . “ (Previously Eurachem Guidance Document No 1/WELAC Guidance Document No. WGD 2) ” . In Guidance on the interpretation of the EN 45001 series of standards and ISO/IEC Guide 25 , Teddington, , UK : Laboratory of the Government Chemist .
  • Valcárcel , M. and Ríos , A. 1993 . The hierarchy and relationships of analytical properties . Anal. Chem. , 65 : 781A – 787A .
  • Ríos , A. and Valcárcel , M. 1994 . Representativeness of analytical results . Analyst , 119 : 109 – 112 . [CROSSREF]
  • 1994 . Accuracy (Trueness and Precision) of Measurement Methods and Results. Part I: General Principles and Definitions. , Geneva : ISO . ISO 5725-1
  • García-Campaña , A. , Bosque-Sendra , J. M. , Cuadros-Rodríguez , L. and Almansa-López , E. 2000 . A framework for in-house accuracy validation of analytical procedures . Biomed. Chromatogr. , 14 : 27 – 29 . [CROSSREF] [CSA]
  • EURACHEM . 1998 . The Fitness for Purpose of Analytical Methods. A Laboratory Guide to Method Validation and Related topics , Teddington, , UK : Laboratory of the Government Chemist .
  • 1995 . Validation of Analytical Procedures: Definitions and Terminology . The International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use . 1995 . ICH-Q2A
  • Jenke , D. R. 1996 . Chromatographic method validation: A review of current practices and procedures. III. Ruggedness, re-validation and system suitability . J. Liq. Chrom. & Rel. Technol. , 19 : 1873 – 1891 .
  • Seartz , M. and Krull , I. S. 1997 . Analytical method Development and Validation , p. 67 New York : Marcel Dekker .
  • Green , J. M. 1996 . A practical guide to analytical method validation . Anal. Chem. , 68 : 305A – 309A .
  • Guide , d e . 1992 . Validation Analytique, Rapport d'une Commision de la Société Française Sciences et Techniques Pharmaceutiques (SFSTP). I. Méthodologie . STP Pharma Practiques , 2 : 205 – 226 .
  • Vander Heyden , Y. 1994 . The ruggedness of analytical methods . Analusis , 22 : M27 – M29 .
  • 1994 . Reviewer Guidance: Validation of Chromatographic Methods , Center for Drug Evaluation and Research (CDER), FDA .
  • Li , Y. G. , Li , M. , Chou , G. X. , Wang , Z. T. and Hu , Z. B. 2004 . Ruggedness/robustness evaluation and system suitability test on United States Pharmacopeia XXVI assay ginsenosides in Asian and American ginseng by high-performance liquid chromatography . J. Pharm. Biomed. Anal. , 35 : 1083 – 1091 . [PUBMED] [INFOTRIEVE] [CROSSREF]
  • ICH-Q2B . 1996 . Text on Validation of Analytical Procedures: Methodology . International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use . 1996 .
  • Lang , J. and Bolton , S. M. 1994 . “ A Comprehensive Method Validation Strategy for Bioanalytical Applications in the Pharmaceutical Industry ” . In Pharmaceutical and Biomedical Applications of Liquid Chromatography , Edited by: Fell , A. M. and Riley , C. M. London : Pergamon . ch. 11
  • Bruce , P. , Minkkinen , P. and Riekkola , M. L. 1998 . Practical method validation: validation sufficient for an analysis method . Mikrochim. Acta , 128 : 93 – 106 . [CROSSREF]
  • Vandenbosch , C. , Vannecke , C. and Massart , D. L. 1992 . Optimization of the separation of (6R)- and (6S)-leucovorin and evaluation of the robustness of the optimum . J. Chromatogr. A. , 592 : 37 – 41 . [CROSSREF]
  • Margriet , M. W. , Hendriks , B. , de Boer , J. H. and Doornbos , D. A. 1992 . Multicriteria decision making . Chemometr. Intell. Lab. Syst. , 16 : 175 – 191 . [CROSSREF]
  • Vanbel , P. F. , Tilquin , B. L. and Schoenmakers , P. J. 1995 . Criteria for developing rugged high-performance liquid chromatographic methods . J. Chromatogr. A. , 697 : 3 – 16 . [CROSSREF] [CSA]
  • Goga-Remont , S. , Heinisch , S. and Rocca , J. L. 2000 . Use of optimization software to determine rugged analysis conditions in high-performance liquid chromatography . J. Chromatogr. A , 868 : 13 – 29 . [PUBMED] [INFOTRIEVE] [CROSSREF]
  • Hadjmohammadi , M. R. and Safa , F. 2004 . Multi-criteria decision making in micellar liquid chromatographic separation of chlorophenols . J. Sep. Sci. , 27 : 997 – 1004 . [PUBMED] [INFOTRIEVE] [CROSSREF]
  • de Boer , J. H. , Smilde , A. K. and Doornbos , D. A. 1990 . Introduction of a robustness coefficient in optimization procedures: Implementation in mixture design problems. Part I: Theory . Chemometr. Intell. Lab. Syst. , 7 : 223 – 236 . [CROSSREF]
  • de Boer , J. H. , Smilde , A. K. and Doornbos , D. A. 1991 . Introduction of a robustness coefficient in optimization procedures: Implementation in mixture design problems. Part II: Some practical considerations . Chemometr. Intell. Lab. Syst. , 10 : 325 – 336 . [CROSSREF]
  • de Boer , J. H. , Smilde , A. K. and Doornbos , D. A. 1991 . Introduction of a robustness coefficient in optimization procedures: Implementation in mixture design problems. Part III: Validation and comparison with competing criteria . Chemometr. Intell. Lab. Syst. , 15 : 13 – 28 . [CROSSREF]
  • De Aguiar , P. F. , Vander Heyden , Y. and Massart , D. L. 1997 . Study of different criteria for the selection of a rugged optimum in high performance liquid chromatography optimisation . Anal. Chim. Acta , 348 : 223 – 235 . [CROSSREF]
  • Fabre , H. 1996 . Robustness testing in liquid chromatography and capillary electrophoresis . J. Pharm. Biomed. Anal. , 14 : 1125 – 1132 . [PUBMED] [INFOTRIEVE] [CROSSREF] [CSA]
  • Toasaksiri , S. , Massart , D. L. and Vander Heyden , Y. 2000 . Study of method validation criteria in capillary electrophoresis method for the separation of non-steroidal anti-inflammatory drugs . Anal. Chim. Acta , 416 : 29 – 42 . [CROSSREF]
  • Fabre , H. and Mesplet , N. 2000 . Robustness testing for a capillary electrophoresis method using the “short-end injection” technique . J. Chromatogr. A , 897 : 329 – 338 . [PUBMED] [INFOTRIEVE] [CROSSREF]
  • Jimidar , M. , Van Ael , W. , De Smet , M. and Cockaers , J. 2001 . Method validation and robustness testing of an enantioselective CE methods for chemical quality control . LC-GC. Europe , 15 : 230 – 242 .
  • Maštovská , K. , Hajšlová , J. and Lehotay , S. J. 2004 . Ruggedness and other performance characteristics of low-pressure gas chromatography-mass spectrometry for the fast analysis of multiple pesticide residues in food crops . J. Chromatogr. A , 1054 : 335 – 349 . [CROSSREF]
  • Vander Heyden , Y. , Hartmann , C. , Massart , D. L. , Nuyten , P. , Hollands , A. M. and Schoenmakers , P. 1996 . Ruggedness testing of a size-exclusion chromatography assay for low-molecular-mass polymers . J. Chromatogr. A , 756 : 89 – 106 . [CROSSREF]
  • Karmarkar , S. , Koberda , M. , Momani , J. , Kotecki , D. and Garber , R. 2004 . Validated ion-exclusion chromatographic method for citrate and acetate in medical fluids . J. Chromatogr. A , 1039 : 147 – 153 . [PUBMED] [INFOTRIEVE] [CROSSREF]
  • Vial , J. and Jardy , A. 1998 . Utilisation des plans d'expériences pour évaluer la robustesse d'une méthode d'analyse quantitative par chromatographie en phase liquide . Analusis , 26 : 15 – 24 . [CROSSREF]
  • Marengo , E. , Gennaro , M. C. , Gianotti , V. and Angelino , S. 2001 . A test of robustness in IIR-RP-HPLC separation of nine priority pollutant phenols . J. Liq. Chrom. Rel. Tech. , 24 : 341 – 353 . [CROSSREF]
  • Romero , R. , Sánchez-Viñas , M. , Gázquez , D. , Bagur , M. G. and Cuadros-Rodríguez , L. 2001 . Robustness study for the determination of biogenic amines by HPLC . Chromatographia , 53 : 481 – 484 .
  • Day , J. A. , Montes-Bayón , M. , Vonderheide , A. P. and Caruso , J. A. 2002 . A study of method robustness for arsenic speciation in drinking water samples by anion exchange HPLC-ICP-MS . Anal. Bioanal. Chem. , 373 : 664 – 668 . [PUBMED] [INFOTRIEVE] [CROSSREF] [CSA]
  • Marcos , J. , Rios , A. and Valcárcel , M. 1996 . Assessment of analytical quality in automatic flow systems . Fresenius J. Anal. Chem. , 354 : 140 – 149 .
  • Álvares-Ribero , L. M. B. C. and Machado , A. A. S. C. 1997 . Usefulness of a ruggedness test in the validation of flow injection analysis systems . Anal. Chim. Acta , 355 : 195 – 201 . [CROSSREF]
  • Gámiz-Gracia , L. and Luque de Castro , M. D. 1997 . Development and validation of a flow-inyection method for the determination of albumin tannate, the active component of a pharmaceutical preparation . J. Pharm. Biom. Anal. , 15 : 447 – 452 . [CROSSREF] [CSA]
  • Cuadros-Rodríguez , L. , Blanc-García , R. , García-Campaña , A. and Bosque-Sendra , J. M. 1998 . A new approach to a complete robustness test of experimental nominal conditions of chemical testing procedures for internal analytical quality assessment . Chemometr. Intell. Lab. Syst. , 41 : 57 – 68 . [CROSSREF]
  • Aybar Muñoz , J. , García-Campaña , A. and Cuadros-Rodríguez , L. 2002 . Evaluating the significance threshold in robutness testing. A critical discussion on the influence of time in molecular florescence spectrometry . Talanta , 56 : 123 – 136 . [CROSSREF]
  • Bosque-Sendra , J. M. , Nechar , M. and Cuadros-Rodríguez , L. 1999 . Decision protocol for checking robustness with previous outlier detection in the validation of analytical method . Fresenius J. Anal. Chem. , 365 : 480 – 488 . [CROSSREF]
  • Furlanetto , S. , Pinzauti , S. , Gratteri , P. , La Porta , E. and Calzeroni , G. 1997 . Experimental design strategies in the optimization and robustness testing of adsorptive stripping voltammetric conditions for kynurenic acid determination . J. Pharm. Biomed. Anal. , 15 : 1585 – 1594 . [PUBMED] [INFOTRIEVE] [CROSSREF] [CSA]
  • Sanz , M. B. , Sarabia , L. A. , Herrero , A. and Ortiz , M. C. 2002 . A study of robustness with multivariate calibration. Application to the polarographic determination of benzaldehyde . Talanta , 56 : 1039 – 1048 . [CROSSREF]
  • Lavertu , M. , Xia , Z. , Serreqi , A. N. , Berrada , M. , Rodrigues , A. , Wang , D. , Buschmann , M. D. and Gupta , A. 2003 . A validated 1H NMR method for the determination of the degree of deacetylation of chitosan . J. Pharm. Biomed. Anal. , 32 : 1149 – 1158 . [PUBMED] [INFOTRIEVE] [CROSSREF] [CSA]
  • Egea González , F. J. , Hernández Torres , M. E. , Garrido Frenich , A. , Martínez Vidal , J. L. and García Campaña , A. M. 2004 . Internal quality-control and laboratory-management tools for enhancing the stability of results in pesticide multi-residue analytical methods . Trends Anal. Chem. , 23 : 361 – 369 . [CROSSREF]
  • Wernimont , G. T. 1997 . Ruggedness evaluation of test procedures . ASTM Standardization News , 5 : 13 – 16 .
  • Youden , W. J. and Steiner , E. H. 1975 . Statistical Manual of the Association of Official Analytical Chemists , pp. 33 – 36 . 70 – 71 . 82 – 83 . Arlington : AOAC .
  • Mulholland , M. 1988 . Ruggedness testing in analytical chemistry . Trends Anal. Chem. , 7 : 383 – 389 . [CROSSREF]
  • Vander Heyden , Y. , Khots , M. S. and Massart , D. L. 1993 . Three-level screening designs for the optimisation or the ruggedness testing of analytical procedures . Anal. Chim. Acta , 276 : 189 – 195 . [CROSSREF]
  • Vander Heyden , Y. , Luypaert , K. , Hartmann , C. , Massart , D. L. , Hoogmartens , J. and De Beer , J. 1995 . Ruggedness tests on the high-performance liquid chromatography assay of the United States Pharmacopeia XXII for tetracycline hydrochloride. A comparison of experimental designs and statistical interpretations . Anal. Chim. Acta , 312 : 245 – 262 . [CROSSREF]
  • Nijhuis , A. , Van der Knaap , H. C. M. , De Jong , S. and Vandeginste , B. G. M. 1999 . Strategy for ruggedness tests in chromatographic method validation . Anal. Chim. Acta , 391 : 187 – 202 . [CROSSREF]
  • Vander Heyden , Y. and Massart , D. L. 1996 . “ Review of the use of robustness and ruggedness in Analytical Chemistry ” . In Robustness of Analytical Methods and Pharmaceutical Technological Products , Edited by: Smilde , A. , de Boer , J. and Hendriks , M. pp. 79 – 147 . Amsterdam : Elsevier .
  • Vander Heyden , Y. , Nijhuis , A. , Smeyers-Verbeke , J. , Vandeginste , B. G. M. and Massart , D. L. 2001 . Guidance for robustness/ruggedness tests in method validation . J. Pharm. Biomed. Anal. , 24 : 723 – 753 . Available also inhttp://minf.vub.ac.be/~fabi/validation/robust/index.html [PUBMED] [INFOTRIEVE] [CROSSREF] [CSA]
  • van Leeuwen , J. A. , Buydens , L. M. C. , Vandegiste , B. G. M. , Kateman , G. , Schoenmakers , P. J. and Mulholland , M. 1991 . RES, an expert system for the set-up and interpretation of a ruggedness test in HPLC method validation. Part 1: The ruggedness test in HPLC method validation . Chemometr. Intell. Lab. Syst. , 10 : 337 – 347 . [CROSSREF]
  • van Leeuwen , J. A. , Buydens , L. M. C. , Vandegiste , B. G. M. , Kateman , G. , Schoenmakers , P. J. and Mulholland , M. 1991 . RES, an expert system for the set-up and interpretation of a ruggedness test in HPLC method validation. Part 2: The ruggedness expert system . Chemometr. Intell. Lab. Syst. , 11 : 37 – 55 . [CROSSREF]
  • van Leeuwen , J. A. , Buydens , L. M. C. , Vandegiste , B. G. M. , Kateman , G. , Cleland , A. , Mulholland , M. , Jansen , C. , Maris , F. A. , Hoogkamer , P. H. and van der Berg , J. H. M. 1991 . RES, an expert system for the set-up and interpretation of a ruggedness test in HPLC method validation. Part 3: The evaluation . Chemometr. Intell. Lab. Syst. , 11 : 161 – 174 . [CROSSREF]
  • Romero , R. , Gázquez , D. , Sánchez-Viñas , M. , Cuadros-Rodríguez , L. and Bagur , M. G. 2002 . A geometric approach to robustness testing in analytical HPLC . LC-GC North Am. , 20 : 72 – 80 .
  • Van Leeuwe , J. A. , Vandeginste , B. G. M. , Kateman , G. , Mulholland , M. and Cleland , A. 1990 . An expert system for the choice of factor for a ruggedness test in liquid chromatography . Anal. Chim. Acta , 228 : 145 – 153 .
  • Vander Heyden , Y. , Questier , F. and Massart , D. L. 1998 . A ruggedness test strategy for procedure related factors: Experimental set-up and interpretation . J. Pharm. Biomed. Anal. , 17 : 153 – 168 . [CSA]
  • Vander Heyden , Y. , Questier , F. and Massart , D. L. 1998 . Ruggedness testing of chromatographic methods: Selection of factors and levels . J. Pharm. Biomed. Anal. , 18 : 43 – 56 . [PUBMED] [INFOTRIEVE] [CROSSREF] [CSA]
  • EUROCHEM/CITAC Guide, QUAM: 2000. P1 . 2000 . Quantifying Uncertainty in Analytical Measurements , 2nd edition
  • Vander Heyden , Y. , Hartmann , C. , Massart , D. L. , Michel , L. , Kiechle , P. and Erni , F. 1995 . Ruggedness tests on an HPLC assay: Comparison of tests at two and three levels by using two-level Plackett-Burman designs . Anal. Chim. Acta , 316 : 15 – 26 . [CROSSREF]
  • Vander Heyden , Y. , Kuttatharmmakul , S. , Smeyers-Verbeke , J. and Massart , D. L. 2000 . Supersaturated designs for robustness testing . Anal. Chem. , 72 : 2869 – 2874 . [PUBMED] [INFOTRIEVE] [CROSSREF]
  • Vander Heyden , Y. , Jimidar , M. , Hund , E. , Niemeijer , N. , Peeters , R. , Smeyers-Verbeke , J. , Massart , D. L. and Hoogmartens , J. 1999 . Determination of system suitability limits with a robustness test . J. Chromatogr. A , 845 : 145 – 154 . [CROSSREF]
  • Hund , E. , Vander Heyden , Y. , Haustein , M. , Massart , D. L. and Smeyers-Verbeke , J. 2000 . Comparison of several criteria to decide on the significance of effects in a robustness test with an asymmetrical factorial design . Anal. Chim. Acta , 404 : 257 – 271 . [CROSSREF]
  • Ragonese , R. , Macka , M. , Hughes , J. and Petcocz , P. 2002 . The use the Box-Behnken experimental design in the optimization and robustness testing of a capillary electrophoresis method for the analysis of ethambutol hydrochloride in a pharmaceutical formulation . J. Pharm. Biomed. Anal. , 17 : 995 – 1107 . [CROSSREF]
  • Vander Heyden , Y. , De Braekeleer , K. , Zhu , Y. , Roets , E. , Hoogmartens , J. , De Beer , J. and Massart , D. L. 1999 . Nested designs in ruggedness testing . J. Pharm. Biomed. Anal. , 20 : 875 – 887 . [PUBMED] [INFOTRIEVE] [CROSSREF] [CSA]
  • Vander Heyden , Y. , Bourgeois , A. and Massart , D. L. 1997 . Influence of the sequence of experiments in a ruggedness test when drift occurs . Anal. Chim. Acta , 347 : 369 – 384 . [CROSSREF]
  • Hund , E. , Massart , D. L. and Smeyers-Verbeke , J. 2002 . Robust regression and outlier detection in the evaluation of robustness tests with different experimental designs . Anal. Chim. Acta , 463 : 53 – 73 . [CROSSREF]
  • Mullholland , M. and Waterhouse , J. 1987 . Development and evaluation of an automated procedure for the ruggedness testing of chromatographic conditions in high-performance liquid chromatography . J. Chromatogr. , 395 : 539 – 551 . [CROSSREF]
  • Hund , E. , Vander Heyden , Y. , Massart , D. L. and Smeyers-Verbeke , J. 2002 . Derivation of system suitability test limits from a robustness test on an LC assay with complex antibiotic samples . J. Pharm. Biomed. Anal. , 30 : 1197 – 1206 . [PUBMED] [INFOTRIEVE] [CROSSREF] [CSA]
  • Vander Heyden , Y. , Massart , D. L. , Zhu , Y. , Hoogmartens , J. and De Beer , J. 1996 . Ruggedness test on the high performance liquid chromatography assay of the United States Pharmacopeia 23 for tetracycline· HCl: Comparison of different columns in a interlaboratory approach . J. Pharm. Biomed. Anal. , 14 : 1313 – 1326 . [CROSSREF] [CSA]
  • Jimidar , M. , Niemeijer , N. , Peeters , R. and Hoogmartens , J. 1998 . Robustness testing of a liquid chromatography method for the determination of vorozole and its related compounds in oral tablets . J. Pharm. Biomed. Anal. , 18 : 479 – 485 . [PUBMED] [INFOTRIEVE] [CROSSREF] [CSA]
  • ISO . 1995 . Guide to the Expression of Uncertainty in Measurement (GUM) , Geneva : ISO .

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.