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Quality by Design in the development of hydrophilic interaction liquid chromatography method with gradient elution for the analysis of olanzapine

Authorized Users Only
2017
Authors
Tumpa, Anja
Stajić, Ana
Jančić-Stojanović, Biljana
Medenica, Mirjana
Article (Published version)
Metadata
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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.
Source:
Journal of Pharmaceutical and Biomedical Analysis, 2017, 134, 18-26
Publisher:
  • Elsevier Science BV, Amsterdam
Funding / projects:
  • Modelling of different chromatographic systems with chemometrical approach in pharmaceutical analysis (RS-172052)

DOI: 10.1016/j.jpba.2016.11.010

ISSN: 0731-7085

PubMed: 27871053

WoS: 000392909900003

Scopus: 2-s2.0-84996614749
[ Google Scholar ]
31
24
URI
https://farfar.pharmacy.bg.ac.rs/handle/123456789/2958
Collections
  • Radovi istraživača / Researchers’ publications
Institution/Community
Pharmacy
TY  - 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 . .

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