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Robust Optimization of Chaotropic Chromatography Assay for Lamotrigine and its Two Impurities in Tablets

Authorized Users Only
2019
Authors
Colović, Jelena
Rmandić, Milena
Malenović, Anđelija
Article (Published version)
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Abstract
In this study robust optimization was applied for the development of a reliable analytical assay for lamotrigine, its impurity A, and impurity G in tablets by chaotropic chromatography. The influence of the critical method parameters (acetonitrile content, concentration of chaotropic agent, and pH of the water phase) on the set of selected critical method attributes (retention factor of impurity A, separation factor between lamotrigine and impurity G, and retention factor of impurity G) is studied by Box-Behnken design. Monte Carlo simulations were applied to propagate the errors originating from the model coefficients' calculation to the selected responses and obtain their predictive distribution. Design space was defined (95%) and a working point selected: 23% of acetonitrile in the mobile phase, 77% of water phase containing 140mM of perchloric acid, and pH of the water phase adjusted to 2.50. Further robustness testing was performed by Plackett-Burman design to evaluate the quantit...ative performance of the developed method. The obtained models included not only active main effects but also interactions that were identified as active with the aid of an alias matrix approach and examination of resulting alias plots. The method was validated and its reliability for routine pharmaceutical analysis confirmed. [GRAPHICS] .

Keywords:
Chaotropic chromatography / Lamotrigine / Impurities / Analytical quality by design / Robustness testing of quantitative method performance
Source:
Chromatographia, 2019, 82, 2, 565-577
Publisher:
  • Springer Heidelberg, Heidelberg
Funding / projects:
  • Modelling of different chromatographic systems with chemometrical approach in pharmaceutical analysis (RS-172052)

DOI: 10.1007/s10337-018-3661-7

ISSN: 0009-5893

WoS: 000460411700008

Scopus: 2-s2.0-85057974068
[ Google Scholar ]
4
3
URI
https://farfar.pharmacy.bg.ac.rs/handle/123456789/3310
Collections
  • Radovi istraživača / Researchers’ publications
Institution/Community
Pharmacy
TY  - JOUR
AU  - Colović, Jelena
AU  - Rmandić, Milena
AU  - Malenović, Anđelija
PY  - 2019
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3310
AB  - In this study robust optimization was applied for the development of a reliable analytical assay for lamotrigine, its impurity A, and impurity G in tablets by chaotropic chromatography. The influence of the critical method parameters (acetonitrile content, concentration of chaotropic agent, and pH of the water phase) on the set of selected critical method attributes (retention factor of impurity A, separation factor between lamotrigine and impurity G, and retention factor of impurity G) is studied by Box-Behnken design. Monte Carlo simulations were applied to propagate the errors originating from the model coefficients' calculation to the selected responses and obtain their predictive distribution. Design space was defined (95%) and a working point selected: 23% of acetonitrile in the mobile phase, 77% of water phase containing 140mM of perchloric acid, and pH of the water phase adjusted to 2.50. Further robustness testing was performed by Plackett-Burman design to evaluate the quantitative performance of the developed method. The obtained models included not only active main effects but also interactions that were identified as active with the aid of an alias matrix approach and examination of resulting alias plots. The method was validated and its reliability for routine pharmaceutical analysis confirmed. [GRAPHICS] .
PB  - Springer Heidelberg, Heidelberg
T2  - Chromatographia
T1  - Robust Optimization of Chaotropic Chromatography Assay for Lamotrigine and its Two Impurities in Tablets
VL  - 82
IS  - 2
SP  - 565
EP  - 577
DO  - 10.1007/s10337-018-3661-7
ER  - 
@article{
author = "Colović, Jelena and Rmandić, Milena and Malenović, Anđelija",
year = "2019",
abstract = "In this study robust optimization was applied for the development of a reliable analytical assay for lamotrigine, its impurity A, and impurity G in tablets by chaotropic chromatography. The influence of the critical method parameters (acetonitrile content, concentration of chaotropic agent, and pH of the water phase) on the set of selected critical method attributes (retention factor of impurity A, separation factor between lamotrigine and impurity G, and retention factor of impurity G) is studied by Box-Behnken design. Monte Carlo simulations were applied to propagate the errors originating from the model coefficients' calculation to the selected responses and obtain their predictive distribution. Design space was defined (95%) and a working point selected: 23% of acetonitrile in the mobile phase, 77% of water phase containing 140mM of perchloric acid, and pH of the water phase adjusted to 2.50. Further robustness testing was performed by Plackett-Burman design to evaluate the quantitative performance of the developed method. The obtained models included not only active main effects but also interactions that were identified as active with the aid of an alias matrix approach and examination of resulting alias plots. The method was validated and its reliability for routine pharmaceutical analysis confirmed. [GRAPHICS] .",
publisher = "Springer Heidelberg, Heidelberg",
journal = "Chromatographia",
title = "Robust Optimization of Chaotropic Chromatography Assay for Lamotrigine and its Two Impurities in Tablets",
volume = "82",
number = "2",
pages = "565-577",
doi = "10.1007/s10337-018-3661-7"
}
Colović, J., Rmandić, M.,& Malenović, A.. (2019). Robust Optimization of Chaotropic Chromatography Assay for Lamotrigine and its Two Impurities in Tablets. in Chromatographia
Springer Heidelberg, Heidelberg., 82(2), 565-577.
https://doi.org/10.1007/s10337-018-3661-7
Colović J, Rmandić M, Malenović A. Robust Optimization of Chaotropic Chromatography Assay for Lamotrigine and its Two Impurities in Tablets. in Chromatographia. 2019;82(2):565-577.
doi:10.1007/s10337-018-3661-7 .
Colović, Jelena, Rmandić, Milena, Malenović, Anđelija, "Robust Optimization of Chaotropic Chromatography Assay for Lamotrigine and its Two Impurities in Tablets" in Chromatographia, 82, no. 2 (2019):565-577,
https://doi.org/10.1007/s10337-018-3661-7 . .

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