Rapid UHPLC Method Development for Omeprazole Analysis in a Quality-by-Design Framework and Transfer to HPLC Using Chromatographic Modelling

被引:0
作者
Schmidt, Alexander H. [1 ,2 ]
Stanic, Mijo [1 ]
机构
[1] Deutsch Arzneimittel GmbH & Co KG, Steiner & Co, Berlin, Germany
[2] Free Univ Berlin, Inst Pharm, Berlin, Germany
关键词
LIQUID-CHROMATOGRAPHY; SPACE; ROBUSTNESS; SEPARATION;
D O I
暂无
中图分类号
O65 [分析化学];
学科分类号
070302 ; 081704 ;
摘要
The aim of this study was to apply quality-by-design principles to build in a more scientific and risk-based multifactorial strategy in the development of an ultrahigh-pressure liquid chromatography (UHPLC) method for omeprazole and its related impurities.
引用
收藏
页码:466 / 478
页数:13
相关论文
共 21 条
[1]  
[Anonymous], J CHROMATOGR A
[2]  
[Anonymous], CHROMATOGR TODAY
[3]  
[Anonymous], 2011, EUROPEAN PHARMACOPOE
[4]  
[Anonymous], COMMENTARY EUROPEA S
[5]  
Borges KB, 2010, J AOAC INT, V93, P1811
[6]   Analytical methodologies for the determination of omeprazole:: An overview [J].
Bosch, M. Espinosa ;
Sanchez, A. J. Ruiz ;
Rojas, F. Sanchez ;
Ojeda, C. Bosch .
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2007, 44 (04) :831-844
[7]  
Iuga C, 2009, FARMACIA, V57, P534
[8]   A stepwise strategy employing automated screening and Dry Lab modeling for the development of robust methods for challenging high performance liquid chromatography separations: A case study [J].
Jayaraman, K. ;
Alexander, A. J. ;
Hu, Y. ;
Tomasella, F. P. .
ANALYTICA CHIMICA ACTA, 2011, 696 (1-2) :116-124
[9]  
Juran J. M., 1992, Juran on quality by design: the new steps for planning quality into goods and services
[10]   From Csaba Horvath to Quality by Design: Visualizing Design Space in Selectivity Exploration of HPLC Separations [J].
Molnar, I. ;
Monks, K. E. .
CHROMATOGRAPHIA, 2011, 73 :S5-S14