期刊
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
卷 134, 期 -, 页码 18-26出版社
ELSEVIER SCIENCE BV
DOI: 10.1016/j.jpba.2016.11.010
关键词
AQbD; HILIC; Gradient; Method development; Olanzapine; Impurities
资金
- Ministry of Education, Science and Technological Development of the Republic of Serbia [172052]
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. (C) 2016 Elsevier B.V. All rights reserved.
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