Quality by Design approach in the development of hydrophilic interaction liquid chromatographic method for the analysis of iohexol and its impurities
Само за регистроване кориснике
2015
Чланак у часопису (Објављена верзија)
Метаподаци
Приказ свих података о документуАпстракт
This study presents the development of hydrophilic interaction liquid chromatographic method for the analysis of iohexol, its endo-isomer and three impurities following Quality by Design (QbD) approach. The main objective of the method was to identify the conditions where adequate separation quality in minimal analysis duration could be achieved within a robust region that guarantees the stability of method performance. The relationship between critical process parameters (acetonitrile content in the mobile phase, pH of the water phase and ammonium acetate concentration in the water phase) and critical quality attributes is created applying design of experiments methodology. The defined mathematical models and Monte Carlo simulation are used to evaluate the risk of uncertainty in models prediction and incertitude in adjusting the process parameters and to identify the design space. The borders of the design space are experimentally verified and confirmed that the quality of the method ...is preserved in this region. Moreover, Plackett-Burman design is applied for experimental robustness testing and method is fully validated to verify the adequacy of selected optimal conditions: the analytical column ZIC HILIC (100 mm x 4.6 mm, 5 mu m particle size); mobile phase consisted of acetonitrile-water phase (72 mM ammonium acetate, pH adjusted to 6.5 with glacial acetic acid) (86.7:13.3) v/v; column temperature 25 degrees C, mobile phase flow rate 1 mL min(-1), wavelength of detection 254 nm.
Кључне речи:
Quality by Design / Design space / Iohexol / Impurities / HILICИзвор:
Journal of Pharmaceutical and Biomedical Analysis, 2015, 110, 42-48Издавач:
- Elsevier Science BV, Amsterdam
Финансирање / пројекти:
- Моделовање различитих хроматографских система са хемометријским приступом у фармацеутској анализи (RS-MESTD-Basic Research (BR or ON)-172052)
Напомена:
- Peer-reviewed manuscript: http://farfar.pharmacy.bg.ac.rs/handle/123456789/3418
DOI: 10.1016/j.jpba.2015.02.046
ISSN: 0731-7085
PubMed: 25796982
WoS: 000353610800006
Scopus: 2-s2.0-84924933726
Институција/група
PharmacyTY - JOUR AU - Jovanović, Marko AU - Rakić, Tijana AU - Tumpa, Anja AU - Jančić-Stojanović, Biljana PY - 2015 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2398 AB - This study presents the development of hydrophilic interaction liquid chromatographic method for the analysis of iohexol, its endo-isomer and three impurities following Quality by Design (QbD) approach. The main objective of the method was to identify the conditions where adequate separation quality in minimal analysis duration could be achieved within a robust region that guarantees the stability of method performance. The relationship between critical process parameters (acetonitrile content in the mobile phase, pH of the water phase and ammonium acetate concentration in the water phase) and critical quality attributes is created applying design of experiments methodology. The defined mathematical models and Monte Carlo simulation are used to evaluate the risk of uncertainty in models prediction and incertitude in adjusting the process parameters and to identify the design space. The borders of the design space are experimentally verified and confirmed that the quality of the method is preserved in this region. Moreover, Plackett-Burman design is applied for experimental robustness testing and method is fully validated to verify the adequacy of selected optimal conditions: the analytical column ZIC HILIC (100 mm x 4.6 mm, 5 mu m particle size); mobile phase consisted of acetonitrile-water phase (72 mM ammonium acetate, pH adjusted to 6.5 with glacial acetic acid) (86.7:13.3) v/v; column temperature 25 degrees C, mobile phase flow rate 1 mL min(-1), wavelength of detection 254 nm. PB - Elsevier Science BV, Amsterdam T2 - Journal of Pharmaceutical and Biomedical Analysis T1 - Quality by Design approach in the development of hydrophilic interaction liquid chromatographic method for the analysis of iohexol and its impurities VL - 110 SP - 42 EP - 48 DO - 10.1016/j.jpba.2015.02.046 ER -
@article{ author = "Jovanović, Marko and Rakić, Tijana and Tumpa, Anja and Jančić-Stojanović, Biljana", year = "2015", abstract = "This study presents the development of hydrophilic interaction liquid chromatographic method for the analysis of iohexol, its endo-isomer and three impurities following Quality by Design (QbD) approach. The main objective of the method was to identify the conditions where adequate separation quality in minimal analysis duration could be achieved within a robust region that guarantees the stability of method performance. The relationship between critical process parameters (acetonitrile content in the mobile phase, pH of the water phase and ammonium acetate concentration in the water phase) and critical quality attributes is created applying design of experiments methodology. The defined mathematical models and Monte Carlo simulation are used to evaluate the risk of uncertainty in models prediction and incertitude in adjusting the process parameters and to identify the design space. The borders of the design space are experimentally verified and confirmed that the quality of the method is preserved in this region. Moreover, Plackett-Burman design is applied for experimental robustness testing and method is fully validated to verify the adequacy of selected optimal conditions: the analytical column ZIC HILIC (100 mm x 4.6 mm, 5 mu m particle size); mobile phase consisted of acetonitrile-water phase (72 mM ammonium acetate, pH adjusted to 6.5 with glacial acetic acid) (86.7:13.3) v/v; column temperature 25 degrees C, mobile phase flow rate 1 mL min(-1), wavelength of detection 254 nm.", publisher = "Elsevier Science BV, Amsterdam", journal = "Journal of Pharmaceutical and Biomedical Analysis", title = "Quality by Design approach in the development of hydrophilic interaction liquid chromatographic method for the analysis of iohexol and its impurities", volume = "110", pages = "42-48", doi = "10.1016/j.jpba.2015.02.046" }
Jovanović, M., Rakić, T., Tumpa, A.,& Jančić-Stojanović, B.. (2015). Quality by Design approach in the development of hydrophilic interaction liquid chromatographic method for the analysis of iohexol and its impurities. in Journal of Pharmaceutical and Biomedical Analysis Elsevier Science BV, Amsterdam., 110, 42-48. https://doi.org/10.1016/j.jpba.2015.02.046
Jovanović M, Rakić T, Tumpa A, Jančić-Stojanović B. Quality by Design approach in the development of hydrophilic interaction liquid chromatographic method for the analysis of iohexol and its impurities. in Journal of Pharmaceutical and Biomedical Analysis. 2015;110:42-48. doi:10.1016/j.jpba.2015.02.046 .
Jovanović, Marko, Rakić, Tijana, Tumpa, Anja, Jančić-Stojanović, Biljana, "Quality by Design approach in the development of hydrophilic interaction liquid chromatographic method for the analysis of iohexol and its impurities" in Journal of Pharmaceutical and Biomedical Analysis, 110 (2015):42-48, https://doi.org/10.1016/j.jpba.2015.02.046 . .