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

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• 作者：Anja Tumpa^a ; Ana Stajić^a ; Biljana Jančić-Stojanović^a ; ^{jancic.stojanovic@pharmacy.bg.ac.rs} ; Mirjana Medenica^b
• 关键词：AQbD ; HILIC ; Gradient ; Method development ; Olanzapine ; Impurities
• 刊名：Journal of Pharmaceutical and Biomedical Analysis
• 出版年：2017
• 出版时间：5 February 2017
• 年：2017
• 卷：134
• 期：Complete
• 页码：18-26
• 全文大小：2498 K
• 卷排序：134

文摘

The first gradient HILIC method developed in accordance with AQbD. For complex HILIC method well defined design space was created. Olanzapine and its seven impurities investigated in HILIC for the first time. Method was fully validated and applied for real sample analysis.