Literature

So far, more than 260 peer reviewed papers have been published on the application of DryLab – a complete list of which you can find here.

DryLab draws on the philosophy described in the three most famous Solvophobic Theory papers IIIIII of Csaba Horváth, which were developed in the years 1975-1977 at Yale University (see also literature by Dr. Imre Molnár).

Read more about the Fundamentals of DryLab and its History.

Keyword Year

Simultaneous optimization of mobile phase composition and pH using retention modeling and experimental design

N. Rácz, I. Molnár, A. Zöldhegyi, H.-J. Rieger, R. Kormány
J Pharm Biomed Anal., 160, 25 October 2018, 336-343 (2018)

Keywords: Early-stage robustness calculation, Mobile phase effects, DryLab, Software-assisted method development, UHPLC, HPLC modeling

PDF
http://doi.org/10.1016/j.jpba.2018.07.054

Chromatographic methods are progressing continuously. Increasing sample complexity and safety expectations lead to higher regulatory demands, hence challenges in liquid chromatography analysis are rising, even today, when faster and faster chromatographic systems are extensively employed and become widely accessible for successful method development.

The goal of this study was to investigate the impact of mobile phase influences as important factors of selectivity tuning in method development. This would mitigate mobile phase-related robustness issues throughout the method's lifecycle.

To discover and understand these effects, a new module of chromatographic modeling software DryLab (ver. 4.3.4. beta) was introduced and a special experimental design (DoE) was tested, allowing the simultaneous optimization of solvent-dependent parameters, such as gradient time (tG), ternary eluent composition (tC) and pH, requiring 18 input experiments (2 × 3 × 3 = 18).

Additionally, the model creation, using a UPLC system and a narrow bore column (50 × 2.1 mm), the entire experimental work could be finished in 2-3 hours. To demonstrate the applicability of this new design, amlodipine and its related pharmacopoeia impurities (A-H) were subjected to be used in a case study. Predicted vs. Experimental (or Verification) runs showed excellent agreement, average retention time deviations were typically less than 1 s. Modelled robustness testing was also performed, elucidating all important mobile phase and instrument parameters that could influence a method's lifetime performance. Furthermore, as the in silico robustness testing is the least time consuming part of the method development process, it can be used extensively to evaluate robustness even at the very early part in stage 1 of the Method Life Cycle (MLC).


Structure assisted impurity profiling for rapid method development in liquid chromatography

S. Schmidtsdorff, A. H. Schmidt, M. K. Parr
J. Chromatogr. A, 1577, 23 November, 38–46 (2018)

Keywords: Distribution coefficient (logD), Method development, Quality-by-design (QbD), High-performance liquid chromatography (HPLC), Chromatographic modeling, Extended knowledge space

PDF
http://doi.org/10.1016/j.chroma.2018.09.044

Highlights:

  • Proper correlation between logD and relative retention in LC.
  • logD calculation is a good basis for starting method screening.
  • Drylab software modeling tool to comply analytical QbD requirements in regards to lifecycle principles.
  • In silico generation of extended knowledge space possible.
  • Extreme high robustness of resulting HPLC method with improved reliability and understanding.

 


An overview of experimental designs in HPLC method development and validation

Prafulla Kumar Sahu et al.
Journal of Pharmaceutical and Biomedical Analysis, 147, 5 January, 590-611 (2018)

Keywords: Chemometry, Screening designs, Optimization designs, Method development/validation, Mathematical modelling, Quality by design, Six sigma

PDF
http://doi.org/10.1016/j.jpba.2017.05.006

Highlights:

  • A first of its kind review on use of experimental designs in HPLC method development and validation.
  • The accuracy of simulated robustness testof a LC method was evaluated using modeling software DryLab.
  • Deals with recent advances in mathematical modeling, screening and optimization designs.
  • Discusses various applications of chemometry in sample preparation, dissolution studies, stability-indicating assays.
  • Demonstrates complex multi component UPLC and LC–MS separations with improved reliability.
  • Describes the quality by design paradigm and the six sigma practices as quality indicators.

 


Utility of a high coverage phenyl-bonding and wide-pore superficially porous particle for the analysis of monoclonal antibodies and related products

Balázs Bobály et al.
Journal of Chromatography A, 1549, 11 May, 63-76 (2018)

Keywords: Superficially porous, Wide-pore, Phenyl bonding, Column efficiency, Monoclonal antibody, Antibody-drug-conjugate

PDF
http://doi.org/10.1016/j.chroma.2018.03.043

Highlights:

  • A wide-pore silica-based SPP material with a high coverage phenyl bonding was evaluated.
  • Kinetic performance, recovery and selectivity were systematically studied.
  • Optimal conditions were determined using Drylab 4 software.
  • The possibility to replace TFA with FA was studied.
  • The new column was applied for the separation of mAb sub-units and ADC species.

 


Enantioselective multiple heartcut two-dimensional ultra-high-performance liquid chromatography method with a Coreshell chiral stationary phase in the second dimension for analysis of all proteinogenic amino acids in a single run

Ulrich Woiwode et al.
Journal of Chromatography A, 1562, 10 August, 69-77 (2018)

Keywords: Two-dimensional liquid chromatography, Chiral stationary phase, Superficially porous particle, Quinine, Non-ribosomal peptides, Sanger’s reagent

PDF
http://doi.org/10.1016/j.chroma.2018.05.062

Highlights:

  • A multiple heartcut 2D-UHPLC-UV method for enantioselective amino acid analysis.
  • Achiral gradient RPLC separation with 1.8 μm C18 phase in the first dimension (1D).
  • the 1D RPLC gradient separation has been established by DryLab based on two linear gradients.
  • Enantioselective separation on tert-butylcarbamoylquinine Coreshell column in 2D.
  • Twenty five N-2,4-dinitrophenyl amino acids analyzed enantioselectively in a fully automated manner in a single run.
  • Applicability documented by structural characterization of non-ribosomal peptides.

 


Identification of cis/trans isomers of menaquinone-7 in food as exemplified by dietary supplements

A. Szterk, A. Zmysłowski, K. Bus
Food Chemistry, 243, 15 March, 403-409 (2018)

Keywords: Menaquinone-7, Vitamin K2MK-7, Impurities of dietary supplements, Cis/trans isomers

PDF
http://doi.org/10.1016/j.foodchem.2017.10.001

Highlights:

  • New method of marking the six different isomers of vitamin K2MK-7.
  • The chromatographic conditions were optimized with DryLab 2000.
  • 5 different isomers of cis/trans vitamin K2MK-7 were identified and detected.
  • Cis/trans isomers exceeded the content of all trans K2MK-7 form even 3.7 times.

 

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