Development of Analytical Quality by Design Compliant Chaotropic Chromatography Method for Ziprasidone and Its Five Impurities Determination
Аутори
Rmandić, MilenaVasilić, Đorđe
Rašević, Marija
Zečević, Mira
Otašević, Biljana
Protić, Ana
Malenović, Anđelija
Чланак у часопису (Објављена верзија)
Метаподаци
Приказ свих података о документуАпстракт
In this study, an AQbD-compliant chaotropic chromatography method for ziprasidone and the determination of its five impurities was developed. The influence of critical method parameters (initial and final methanol fraction in the mobile phase, gradient duration) on the set of selected critical method attributes (t_imp. V, t_imp. V − t_imp. I, S and <WUSP>) was studied by Box–Behnken design. The errors resulting from the calculation of the model coefficients were propagated to the selected responses by Monte Carlo simulations, and their predictive distribution was obtained. The design space was computed (π ≥ 80%), and a working point was selected: initial methanol fraction 38.5%, final methanol fraction 77.5%, and gradient duration 16.25 min. Furthermore, the quantitative robustness of the developed method was tested using the Plackett–Burman design. P_imp II and P_imp V were found to be significantly affected, the first by mobile phase flow rate and the second by gradient duration. Fin...ally, the method was validated, and its reliability for routine quality control in capsules was confirmed.
Кључне речи:
analytical quality by design / chaotropic chromatography / impurities / robustness testing of method quantitative performances / ziprasidoneИзвор:
Pharmaceuticals, 2023, 16, 9Издавач:
- MDPI
Финансирање / пројекти:
- Министарство науке, технолошког развоја и иновација Републике Србије, институционално финансирање - 200161 (Универзитет у Београду, Фармацеутски факултет) (RS-MESTD-inst-2020-200161)
DOI: 10.3390/ph16091296
ISSN: 1424-8247
PubMed: 37765104
Scopus: 2-s2.0-85172212846
Институција/група
PharmacyTY - JOUR AU - Rmandić, Milena AU - Vasilić, Đorđe AU - Rašević, Marija AU - Zečević, Mira AU - Otašević, Biljana AU - Protić, Ana AU - Malenović, Anđelija PY - 2023 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/5055 AB - In this study, an AQbD-compliant chaotropic chromatography method for ziprasidone and the determination of its five impurities was developed. The influence of critical method parameters (initial and final methanol fraction in the mobile phase, gradient duration) on the set of selected critical method attributes (t_imp. V, t_imp. V − t_imp. I, S and <WUSP>) was studied by Box–Behnken design. The errors resulting from the calculation of the model coefficients were propagated to the selected responses by Monte Carlo simulations, and their predictive distribution was obtained. The design space was computed (π ≥ 80%), and a working point was selected: initial methanol fraction 38.5%, final methanol fraction 77.5%, and gradient duration 16.25 min. Furthermore, the quantitative robustness of the developed method was tested using the Plackett–Burman design. P_imp II and P_imp V were found to be significantly affected, the first by mobile phase flow rate and the second by gradient duration. Finally, the method was validated, and its reliability for routine quality control in capsules was confirmed. PB - MDPI T2 - Pharmaceuticals T1 - Development of Analytical Quality by Design Compliant Chaotropic Chromatography Method for Ziprasidone and Its Five Impurities Determination VL - 16 IS - 9 DO - 10.3390/ph16091296 ER -
@article{ author = "Rmandić, Milena and Vasilić, Đorđe and Rašević, Marija and Zečević, Mira and Otašević, Biljana and Protić, Ana and Malenović, Anđelija", year = "2023", abstract = "In this study, an AQbD-compliant chaotropic chromatography method for ziprasidone and the determination of its five impurities was developed. The influence of critical method parameters (initial and final methanol fraction in the mobile phase, gradient duration) on the set of selected critical method attributes (t_imp. V, t_imp. V − t_imp. I, S and <WUSP>) was studied by Box–Behnken design. The errors resulting from the calculation of the model coefficients were propagated to the selected responses by Monte Carlo simulations, and their predictive distribution was obtained. The design space was computed (π ≥ 80%), and a working point was selected: initial methanol fraction 38.5%, final methanol fraction 77.5%, and gradient duration 16.25 min. Furthermore, the quantitative robustness of the developed method was tested using the Plackett–Burman design. P_imp II and P_imp V were found to be significantly affected, the first by mobile phase flow rate and the second by gradient duration. Finally, the method was validated, and its reliability for routine quality control in capsules was confirmed.", publisher = "MDPI", journal = "Pharmaceuticals", title = "Development of Analytical Quality by Design Compliant Chaotropic Chromatography Method for Ziprasidone and Its Five Impurities Determination", volume = "16", number = "9", doi = "10.3390/ph16091296" }
Rmandić, M., Vasilić, Đ., Rašević, M., Zečević, M., Otašević, B., Protić, A.,& Malenović, A.. (2023). Development of Analytical Quality by Design Compliant Chaotropic Chromatography Method for Ziprasidone and Its Five Impurities Determination. in Pharmaceuticals MDPI., 16(9). https://doi.org/10.3390/ph16091296
Rmandić M, Vasilić Đ, Rašević M, Zečević M, Otašević B, Protić A, Malenović A. Development of Analytical Quality by Design Compliant Chaotropic Chromatography Method for Ziprasidone and Its Five Impurities Determination. in Pharmaceuticals. 2023;16(9). doi:10.3390/ph16091296 .
Rmandić, Milena, Vasilić, Đorđe, Rašević, Marija, Zečević, Mira, Otašević, Biljana, Protić, Ana, Malenović, Anđelija, "Development of Analytical Quality by Design Compliant Chaotropic Chromatography Method for Ziprasidone and Its Five Impurities Determination" in Pharmaceuticals, 16, no. 9 (2023), https://doi.org/10.3390/ph16091296 . .