Multi-Level Robustness Evaluation Approach: From Robustness Criterion to Adapted Algorithm of Dong
Samo za registrovane korisnike
2013
Članak u časopisu (Objavljena verzija)
Metapodaci
Prikaz svih podataka o dokumentuApstrakt
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.
Ključne reči:
Column liquid chromatography / Robustness criterion / Adapted algorithm of Dong / Effect sparsityIzvor:
Chromatographia, 2013, 76, 5-6, 267-277Izdavač:
- Springer Heidelberg, Heidelberg
Finansiranje / projekti:
- Modelovanje različitih hromatografskih sistema sa hemometrijskim pristupom u farmaceutskoj analizi (RS-172052)
DOI: 10.1007/s10337-012-2317-2
ISSN: 0009-5893
WoS: 000315567900006
Scopus: 2-s2.0-84878360737
Institucija/grupa
PharmacyTY - 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 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" }
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
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 .
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 . .