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Multi-Level Robustness Evaluation Approach: From Robustness Criterion to Adapted Algorithm of Dong

Само за регистроване кориснике
2013
Аутори
Rakić, Tijana
Vemić, Sava
Jančić-Stojanović, Biljana
Medenica, Mirjana
Чланак у часопису (Објављена верзија)
Метаподаци
Приказ свих података о документу
Апстракт
This paper proposes an innovative concept for robustness evaluation guided by two crucial aims: indubitable identification of the factors that significantly affect the LC method and avoidance of unnecessary time and money wasting. The first phase of the proposed strategy includes robustness screening during the method optimization. Initial assumptions of the method robustness can be tracked as the rate of the response change while the factors deviate within the expected range. Therefore, partial and total robustness criteria are calculated. If the results obtained are not satisfactory, re-optimization of the method should be considered. Otherwise, extensive robustness testing defined by experimental design and multi-level factors estimation should be performed to confirm the method robustness. Firstly, the important factors are investigated by the standard graphical (normal probability plots) and statistical (algorithm of Dong and error estimation based on a priori declared negligible ...effects) procedures. Since these approaches have several drawbacks, they can result in the appearance of false negative or false positive results. Thus, the modification of the statistical tests is advised in order to make the final conclusions. Special attention was dedicated to the advantages of the adapted algorithm of Dong (so-called 75 % approach) in the absence of the effect sparsity. The new approach is presented on the optimization and robustness testing of LC method for determination of ramipril and its five impurities. It is proved that the proposed strategy can perform an overall robustness estimation and successfully reveal all important factors.

Кључне речи:
Column liquid chromatography / Robustness criterion / Adapted algorithm of Dong / Effect sparsity
Извор:
Chromatographia, 2013, 76, 5-6, 267-277
Издавач:
  • Springer Heidelberg, Heidelberg
Финансирање / пројекти:
  • Моделовање различитих хроматографских система са хемометријским приступом у фармацеутској анализи (RS-172052)

DOI: 10.1007/s10337-012-2317-2

ISSN: 0009-5893

WoS: 000315567900006

Scopus: 2-s2.0-84878360737
[ Google Scholar ]
1
1
URI
https://farfar.pharmacy.bg.ac.rs/handle/123456789/1947
Колекције
  • Radovi istraživača / Researchers’ publications
Институција/група
Pharmacy
TY  - JOUR
AU  - Rakić, Tijana
AU  - Vemić, Sava
AU  - Jančić-Stojanović, Biljana
AU  - Medenica, Mirjana
PY  - 2013
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1947
AB  - This paper proposes an innovative concept for robustness evaluation guided by two crucial aims: indubitable identification of the factors that significantly affect the LC method and avoidance of unnecessary time and money wasting. The first phase of the proposed strategy includes robustness screening during the method optimization. Initial assumptions of the method robustness can be tracked as the rate of the response change while the factors deviate within the expected range. Therefore, partial and total robustness criteria are calculated. If the results obtained are not satisfactory, re-optimization of the method should be considered. Otherwise, extensive robustness testing defined by experimental design and multi-level factors estimation should be performed to confirm the method robustness. Firstly, the important factors are investigated by the standard graphical (normal probability plots) and statistical (algorithm of Dong and error estimation based on a priori declared negligible effects) procedures. Since these approaches have several drawbacks, they can result in the appearance of false negative or false positive results. Thus, the modification of the statistical tests is advised in order to make the final conclusions. Special attention was dedicated to the advantages of the adapted algorithm of Dong (so-called 75 % approach) in the absence of the effect sparsity. The new approach is presented on the optimization and robustness testing of LC method for determination of ramipril and its five impurities. It is proved that the proposed strategy can perform an overall robustness estimation and successfully reveal all important factors.
PB  - Springer Heidelberg, Heidelberg
T2  - Chromatographia
T1  - Multi-Level Robustness Evaluation Approach: From Robustness Criterion to Adapted Algorithm of Dong
VL  - 76
IS  - 5-6
SP  - 267
EP  - 277
DO  - 10.1007/s10337-012-2317-2
UR  - conv_2786
ER  - 
@article{
author = "Rakić, Tijana and Vemić, Sava and Jančić-Stojanović, Biljana and Medenica, Mirjana",
year = "2013",
abstract = "This paper proposes an innovative concept for robustness evaluation guided by two crucial aims: indubitable identification of the factors that significantly affect the LC method and avoidance of unnecessary time and money wasting. The first phase of the proposed strategy includes robustness screening during the method optimization. Initial assumptions of the method robustness can be tracked as the rate of the response change while the factors deviate within the expected range. Therefore, partial and total robustness criteria are calculated. If the results obtained are not satisfactory, re-optimization of the method should be considered. Otherwise, extensive robustness testing defined by experimental design and multi-level factors estimation should be performed to confirm the method robustness. Firstly, the important factors are investigated by the standard graphical (normal probability plots) and statistical (algorithm of Dong and error estimation based on a priori declared negligible effects) procedures. Since these approaches have several drawbacks, they can result in the appearance of false negative or false positive results. Thus, the modification of the statistical tests is advised in order to make the final conclusions. Special attention was dedicated to the advantages of the adapted algorithm of Dong (so-called 75 % approach) in the absence of the effect sparsity. The new approach is presented on the optimization and robustness testing of LC method for determination of ramipril and its five impurities. It is proved that the proposed strategy can perform an overall robustness estimation and successfully reveal all important factors.",
publisher = "Springer Heidelberg, Heidelberg",
journal = "Chromatographia",
title = "Multi-Level Robustness Evaluation Approach: From Robustness Criterion to Adapted Algorithm of Dong",
volume = "76",
number = "5-6",
pages = "267-277",
doi = "10.1007/s10337-012-2317-2",
url = "conv_2786"
}
Rakić, T., Vemić, S., Jančić-Stojanović, B.,& Medenica, M.. (2013). Multi-Level Robustness Evaluation Approach: From Robustness Criterion to Adapted Algorithm of Dong. in Chromatographia
Springer Heidelberg, Heidelberg., 76(5-6), 267-277.
https://doi.org/10.1007/s10337-012-2317-2
conv_2786
Rakić T, Vemić S, Jančić-Stojanović B, Medenica M. Multi-Level Robustness Evaluation Approach: From Robustness Criterion to Adapted Algorithm of Dong. in Chromatographia. 2013;76(5-6):267-277.
doi:10.1007/s10337-012-2317-2
conv_2786 .
Rakić, Tijana, Vemić, Sava, Jančić-Stojanović, Biljana, Medenica, Mirjana, "Multi-Level Robustness Evaluation Approach: From Robustness Criterion to Adapted Algorithm of Dong" in Chromatographia, 76, no. 5-6 (2013):267-277,
https://doi.org/10.1007/s10337-012-2317-2 .,
conv_2786 .

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