Statistical method comparison: short- and long-column liquid chromatography assays of ketoconazole and formaldehyde in shampoo
When an analytical method is modified or a new one is developed in order to attain, for instance, shorter analysis times, lower cost or more convenience of use, the new method should be validated before being accepted for routine use. It is also necessary to demonstrate that the new or alternative m...
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Published in | Analytica chimica acta Vol. 516; no. 1; pp. 87 - 106 |
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Main Authors | , , , , , , , |
Format | Journal Article |
Language | English |
Published |
Elsevier B.V
19.07.2004
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Subjects | |
Online Access | Get full text |
ISSN | 0003-2670 1873-4324 |
DOI | 10.1016/j.aca.2004.03.076 |
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Abstract | When an analytical method is modified or a new one is developed in order to attain, for instance, shorter analysis times, lower cost or more convenience of use, the new method should be validated before being accepted for routine use. It is also necessary to demonstrate that the new or alternative method does not have worse performance characteristics than the existing or reference method. Therefore, a comparison of the performances between alternative and reference method should be made. In this comparison, precision and bias are the evaluated performance parameters. With the current tendency to use more frequently short-column methods in HPLC, such method comparisons will become increasingly important. In this paper, two alternative short column HPLC methods to assay ketoconazole and formaldehyde in an anti-dandruff shampoo are compared with the reference method on a long column. The assays were initially developed on such a long column (25
cm). The comparison procedure consists of data visualisation and statistical analysis. It was found that, in the linear concentration ranges of ketoconazole (from 0.05 to 0.15
mg/ml) and formaldehyde (from 3.5×10
−5 to 3.5×10
−4% (m/v)), the alternative methods do not possess neither a statistically worse precision nor an unacceptable bias compared to the reference assays on the long column. Therefore, they can be used as alternatives to the conventional method. |
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AbstractList | When an analytical method is modified or a new one is developed in order to attain, for instance, shorter analysis times, lower cost or more convenience of use, the new method should be validated before being accepted for routine use. It is also necessary to demonstrate that the new or alternative method does not have worse performance characteristics than the existing or reference method. Therefore, a comparison of the performances between alternative and reference method should be made. In this comparison, precision and bias are the evaluated performance parameters. With the current tendency to use more frequently short-column methods in HPLC, such method comparisons will become increasingly important. In this paper, two alternative short column HPLC methods to assay ketoconazole and formaldehyde in an anti-dandruff shampoo are compared with the reference method on a long column. The assays were initially developed on such a long column (25
cm). The comparison procedure consists of data visualisation and statistical analysis. It was found that, in the linear concentration ranges of ketoconazole (from 0.05 to 0.15
mg/ml) and formaldehyde (from 3.5×10
−5 to 3.5×10
−4% (m/v)), the alternative methods do not possess neither a statistically worse precision nor an unacceptable bias compared to the reference assays on the long column. Therefore, they can be used as alternatives to the conventional method. |
Author | Kuttatharmmakul, S. Hu, Y. Smeyers-Verbeke, J. Nguyen Minh Nguyet, A. van Nederkassel, A.M. Hund, E. Vander Heyden, Y. Tallieu, L. |
Author_xml | – sequence: 1 givenname: A. surname: Nguyen Minh Nguyet fullname: Nguyen Minh Nguyet, A. organization: Department of Pharmaceutical and Biomedical Analysis, Pharmaceutical Institute, Vrije Universiteit Brussels (VUB), Laarbeeklaan 103, 1090 Brussels, Belgium – sequence: 2 givenname: A.M. surname: van Nederkassel fullname: van Nederkassel, A.M. organization: Department of Pharmaceutical and Biomedical Analysis, Pharmaceutical Institute, Vrije Universiteit Brussels (VUB), Laarbeeklaan 103, 1090 Brussels, Belgium – sequence: 3 givenname: L. surname: Tallieu fullname: Tallieu, L. organization: Department of Pharmaceutical and Biomedical Analysis, Pharmaceutical Institute, Vrije Universiteit Brussels (VUB), Laarbeeklaan 103, 1090 Brussels, Belgium – sequence: 4 givenname: S. surname: Kuttatharmmakul fullname: Kuttatharmmakul, S. organization: Department of Pharmaceutical and Biomedical Analysis, Pharmaceutical Institute, Vrije Universiteit Brussels (VUB), Laarbeeklaan 103, 1090 Brussels, Belgium – sequence: 5 givenname: E. surname: Hund fullname: Hund, E. organization: Department of Pharmaceutical and Biomedical Analysis, Pharmaceutical Institute, Vrije Universiteit Brussels (VUB), Laarbeeklaan 103, 1090 Brussels, Belgium – sequence: 6 givenname: Y. surname: Hu fullname: Hu, Y. organization: Department of Pharmaceutical and Biomedical Analysis, Pharmaceutical Institute, Vrije Universiteit Brussels (VUB), Laarbeeklaan 103, 1090 Brussels, Belgium – sequence: 7 givenname: J. surname: Smeyers-Verbeke fullname: Smeyers-Verbeke, J. organization: Department of Pharmaceutical and Biomedical Analysis, Pharmaceutical Institute, Vrije Universiteit Brussels (VUB), Laarbeeklaan 103, 1090 Brussels, Belgium – sequence: 8 givenname: Y. surname: Vander Heyden fullname: Vander Heyden, Y. email: yvanvdh@vub.ac.be organization: Department of Pharmaceutical and Biomedical Analysis, Pharmaceutical Institute, Vrije Universiteit Brussels (VUB), Laarbeeklaan 103, 1090 Brussels, Belgium |
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CitedBy_id | crossref_primary_10_1016_j_foodchem_2005_05_007 crossref_primary_10_1016_j_aca_2004_12_056 crossref_primary_10_1016_j_aca_2007_03_002 crossref_primary_10_1002_psc_1436 crossref_primary_10_1002_jssc_200500335 crossref_primary_10_1080_10826076_2012_758145 crossref_primary_10_1016_j_electacta_2010_08_026 crossref_primary_10_1016_j_jpba_2014_07_012 crossref_primary_10_1007_s10463_006_0069_1 crossref_primary_10_3390_nano13030523 crossref_primary_10_1590_s2175_97902019000100087 crossref_primary_10_1016_j_molliq_2018_02_006 crossref_primary_10_1248_cpb_56_143 crossref_primary_10_1016_j_aca_2005_01_060 |
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Keywords | Graphical comparison Statistical comparison Ketoconazole Comparison of measurement methods Formaldehyde Short-column HPLC |
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SubjectTerms | Comparison of measurement methods Formaldehyde Graphical comparison Ketoconazole Short-column HPLC Statistical comparison |
Title | Statistical method comparison: short- and long-column liquid chromatography assays of ketoconazole and formaldehyde in shampoo |
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