Quality by Design in the development of hydrophilic interaction liquid chromatography method with gradient elution for the analysis of olanzapine
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2017
Članak u časopisu (Objavljena verzija)
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This paper deals with the development of hydrophilic interaction liquid chromatography (HILIC) method with gradient elution, in accordance with Analytical Quality by Design (AQbD) methodology, for the first time. The method is developed for olanzapine and its seven related substances. Following step by step AQbD methodology, firstly as critical process parameters (CPPs) temperature, starting content of aqueous phase and duration of linear gradient are recognized, and as critical quality attributes (CQAs) separation criterion S of critical pairs of substances are investigated. Rechtschaffen design is used for the creation of models that describe the dependence between CPPs and CQAs. The design space that is obtained at the end is used for choosing the optimal conditions (set point). The method is fully validated at the end to verify the adequacy of the chosen optimal conditions and applied to real samples.
Izvor:
Journal of Pharmaceutical and Biomedical Analysis, 2017, 134, 18-26Izdavač:
- Elsevier Science BV, Amsterdam
Finansiranje / projekti:
- Modelovanje različitih hromatografskih sistema sa hemometrijskim pristupom u farmaceutskoj analizi (RS-MESTD-Basic Research (BR or ON)-172052)
DOI: 10.1016/j.jpba.2016.11.010
ISSN: 0731-7085
PubMed: 27871053
WoS: 000392909900003
Scopus: 2-s2.0-84996614749
Institucija/grupa
PharmacyTY - JOUR AU - Tumpa, Anja AU - Stajić, Ana AU - Jančić-Stojanović, Biljana AU - Medenica, Mirjana PY - 2017 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2958 AB - This paper deals with the development of hydrophilic interaction liquid chromatography (HILIC) method with gradient elution, in accordance with Analytical Quality by Design (AQbD) methodology, for the first time. The method is developed for olanzapine and its seven related substances. Following step by step AQbD methodology, firstly as critical process parameters (CPPs) temperature, starting content of aqueous phase and duration of linear gradient are recognized, and as critical quality attributes (CQAs) separation criterion S of critical pairs of substances are investigated. Rechtschaffen design is used for the creation of models that describe the dependence between CPPs and CQAs. The design space that is obtained at the end is used for choosing the optimal conditions (set point). The method is fully validated at the end to verify the adequacy of the chosen optimal conditions and applied to real samples. PB - Elsevier Science BV, Amsterdam T2 - Journal of Pharmaceutical and Biomedical Analysis T1 - Quality by Design in the development of hydrophilic interaction liquid chromatography method with gradient elution for the analysis of olanzapine VL - 134 SP - 18 EP - 26 DO - 10.1016/j.jpba.2016.11.010 ER -
@article{ author = "Tumpa, Anja and Stajić, Ana and Jančić-Stojanović, Biljana and Medenica, Mirjana", year = "2017", abstract = "This paper deals with the development of hydrophilic interaction liquid chromatography (HILIC) method with gradient elution, in accordance with Analytical Quality by Design (AQbD) methodology, for the first time. The method is developed for olanzapine and its seven related substances. Following step by step AQbD methodology, firstly as critical process parameters (CPPs) temperature, starting content of aqueous phase and duration of linear gradient are recognized, and as critical quality attributes (CQAs) separation criterion S of critical pairs of substances are investigated. Rechtschaffen design is used for the creation of models that describe the dependence between CPPs and CQAs. The design space that is obtained at the end is used for choosing the optimal conditions (set point). The method is fully validated at the end to verify the adequacy of the chosen optimal conditions and applied to real samples.", publisher = "Elsevier Science BV, Amsterdam", journal = "Journal of Pharmaceutical and Biomedical Analysis", title = "Quality by Design in the development of hydrophilic interaction liquid chromatography method with gradient elution for the analysis of olanzapine", volume = "134", pages = "18-26", doi = "10.1016/j.jpba.2016.11.010" }
Tumpa, A., Stajić, A., Jančić-Stojanović, B.,& Medenica, M.. (2017). Quality by Design in the development of hydrophilic interaction liquid chromatography method with gradient elution for the analysis of olanzapine. in Journal of Pharmaceutical and Biomedical Analysis Elsevier Science BV, Amsterdam., 134, 18-26. https://doi.org/10.1016/j.jpba.2016.11.010
Tumpa A, Stajić A, Jančić-Stojanović B, Medenica M. Quality by Design in the development of hydrophilic interaction liquid chromatography method with gradient elution for the analysis of olanzapine. in Journal of Pharmaceutical and Biomedical Analysis. 2017;134:18-26. doi:10.1016/j.jpba.2016.11.010 .
Tumpa, Anja, Stajić, Ana, Jančić-Stojanović, Biljana, Medenica, Mirjana, "Quality by Design in the development of hydrophilic interaction liquid chromatography method with gradient elution for the analysis of olanzapine" in Journal of Pharmaceutical and Biomedical Analysis, 134 (2017):18-26, https://doi.org/10.1016/j.jpba.2016.11.010 . .