From Csaba Horvath to Quality by Design: Visualizing Design Space in Selectivity Exploration of HPLC Separations

被引:19
作者
Molnar, I. [1 ]
Monks, K. E. [1 ]
机构
[1] Molnar Inst Appl Chromatog, D-10407 Berlin, Germany
关键词
Csaba Horvath; Solvophobic theory; Quality by Design; Design space; 3D computer modeling software; LIQUID-CHROMATOGRAPHY; RETENTION; ACIDS;
D O I
10.1007/s10337-011-1968-8
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
The present paper starts by taking a look back at some of the pioneering work in high pressure liquid chromatography (HPLC) that went on in Csaba Horvath's laboratory in 1970s, through the eyes of I. Molnar. It then goes on to describe a very modern approach to HPLC method development within the Quality by Design framework: the multifactorial optimization of three critical HPLC method parameters, i.e. gradient time (t (G)), temperature (T), and ternary composition (B-1:B-2) based on 12 experiments. The effect of these experimental variables on critical resolution and selectivity was carried out in such a way as to systematically vary all three factors simultaneously.
引用
收藏
页码:S5 / S14
页数:10
相关论文
共 22 条
[1]  
BORMAN, 2007, PHARM TECHNOL, V31, P142
[2]  
Ermer J, 2005, METHOD VALIDATION IN PHARMACEUTICAL ANALYSIS: A GUIDE TO BEST PRACTICE, P1
[3]  
ERNI F, 2008, SCI WORKSH COMP DESI
[4]  
EUERBY M, 2010, CHROMATOGR TODAY, V3, P22
[5]   Rapid high performance liquid chromatography method development with high prediction accuracy, using 5 cm long narrow bore columns packed with sub-2 μm particles and Design Space computer modeling [J].
Fekete, Szabolcs ;
Fekete, Jeno ;
Molnar, Imre ;
Ganzler, Katalin .
JOURNAL OF CHROMATOGRAPHY A, 2009, 1216 (45) :7816-7823
[6]   Validated UPLC method for the fast and sensitive determination of steroid residues in support of cleaning validation in formulation area [J].
Fekete, Szabolcs ;
Fekete, Jeno ;
Ganzler, Katalin .
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2009, 49 (03) :833-838
[7]   LIQUID-CHROMATOGRAPHY OF IONOGENIC SUBSTANCES WITH NONPOLAR STATIONARY PHASES [J].
HORVATH, C ;
MELANDER, W ;
MOLNAR, I .
ANALYTICAL CHEMISTRY, 1977, 49 (01) :142-154
[8]   SOLVOPHOBIC INTERACTIONS IN LIQUID-CHROMATOGRAPHY WITH NONPOLAR STATIONARY PHASES [J].
HORVATH, C ;
MELANDER, W ;
MOLNAR, I .
JOURNAL OF CHROMATOGRAPHY, 1976, 125 (01) :129-156
[9]   ENHANCEMENT OF RETENTION BY ION-PAIR FORMATION IN LIQUID-CHROMATOGRAPHY WITH NONPOLAR STATIONARY PHASES [J].
HORVATH, C ;
MELANDER, W ;
MOLNAR, I ;
MOLNAR, P .
ANALYTICAL CHEMISTRY, 1977, 49 (14) :2295-2305
[10]  
*ICH Q8, 2006, GUID IND PHARM DEV