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

Computer-assisted multifactorial method development for the streamlined separation and analysis of multicomponent mixtures in (Bio)pharmaceutical settings

Mohamed Hemida, Imad A. Haidar Ahmad, Rodell C. Barrientos, Erik L. Regalado
Analytica Chimica Acta, 1293, 8 March, 1-15 (2024)

Keywords: Computer-assisted, Optimization, Liquid chromatography, Method development, Complex mixtures, (Bio)pharmaceuticals

PDF
http://doi.org/10.1016/j.aca.2023.342178

Highlights 

  • Computer-Assisted multifactorial chromatographic strategies were addressed.
  • Using proper linear and non-linear models were discussed.
  • Applications in various chromatographic techniques are critically reviewed.
  • Important parameters for retention mechanism modelling are demonstrated.
  • Computer-Assisted optimization strategies are highlighted for generic methods.

 


Updating the European Pharmacopoeia impurity profiling method for cetirizine and suggesting alternative column, using Design Space Comparison

Róbert Kormány, Barnabás Soós, Krisztián Horváth
Journal of Pharmaceutical and Biomedical Analysis, 237, 5 January , 1-9 (2024)

Keywords: Column comparison, Design of experiments, Method validation, Quality by design, Robustness, Cetirizine

PDF
http://doi.org/10.1016/j.jpba.2023.115776

Highlights

  • A new UHPLC method was developed for cetirizine impurity profiling to update the Ph. Eur. method.
  • A generic workflow has been proposed to suggest replacement columns for a given separation.
  • Column comparison was based on the visualization and overlay of design spaces.
  • The new method was validated in accordance with international guidelines.

 


Revisiting column selectivity choices in ultra-high performance liquid chromatography–Using multidimensional analytical Design Spaces to identify column equivalency

Arnold Zöldhegyi, Krisztián Horváth, Róbert Kormány
Journal of Chromatography A, 1719, 29 March, 1-10 (2024)

Keywords: Analytical quality by design, Method operable design region, Replacement columns, Design space modeling, Qualifying similarity/orthogonality in HPLC

PDF
http://doi.org/10.1016/j.chroma.2024.464738

Highlights 

  • Introducing modeling methodology for a robust assessment of UHPLC column provided selectivities.
  • Multidimensional Design Spaces offering AQbD-compliant alternative for column selectivity testing and comparison methods.
  • Identifying shared method conditions with established interchangeability between various C18 stationary phases.
  • Pharmaceutical application: optimal workpoints, substitute columns, ensure consistency, identification of equivalent/orthogonal column selectivities.  

 


Software-supported HPLC Method Development for Separating Four Regioisomers of a Sugammadex-related Impurity

Dominika Herr, Arnold Zöldhegyi, Péter Soma Szakály, Erzsébet Varga
[Poster Presentation] HPLC 2023 Conference, Düsseldorf, Germany

Keywords: Di-OH-SGM, Qualification of Regioisomers, RP-HPLC modeling for Qualification, Critical method parameters, MS and NMR spectroscopy

PDF

Highlights

  • A systematic modeling approach to contextualize data and optimize critical method parameters of regioisomers of Di-OH-SGM is provided
  • With this, the complex nature and chromatographic behavior of regioisomers of Di-OH-SGM is better understood
  • It is shown how to develop a simple and cost-effective RP-HPLC application for baseline-resolving regioisomers
  • Such an approach is required for the qualification of synthesized Di-OH-SGM material
  • The results of this work can be applied in various fields, including pharmaceuticals, biotechnology, and materials science

 


Expediting the chromatographic analysis of COVID-19 antibody therapeutics with ultra-short columns, retention modeling and automated method development

Bastiaan Duivelshof, Arnold Zöldhegyi, Davy Guillarme, Matthew Lauber, Szabolcs Fekete
J. Pharm. Biomed. Anal., 221, 30 November, 1-8 (2022)

Keywords: Covid-19, Casirivimab, Imdevimab, Ultra-short column, Retention modeling, Automation

PDF
http://doi.org/10.1016/j.jpba.2022.115039

Highlights:

  • Software assisted, automated approach was used for LC method development
  • Ultra-short protein columns enabled 1–2 min analysis time
  • Complete method development for four chromatographic modes required only 2 days
  • Conventional chromatographic techniques can quickly be transferred to short columns

Analytical quality by design-compliant retention modeling for exploring column interchangeabilities in separating ezetimibe and its related substances

Elek Ferencz, Arnold Zöldhegyi, Éva-Katalin Kelemen, Mona Obreja, Imre Molnár
J. Chromatogr. A, 1682, 25 October, 1-11 (2022)

Keywords: Ezetimibe, QBD, DOE, Drylab, Column chemistry, Analytical Quality by Design (AQbD), Design Space Modeling

PDF
http://doi.org/10.1016/j.chroma.2022.463494

Highlights

  • Computer-aided chromatographic method development for the separation of ezetimibe and its related substances
  • Design space comparison - new approach for testing column interchangeability
  • Mechanistic retention modeling and a 3D experimental design based approach via DryLab® software
  • Baseline separation of the analytes achieved on nine different stationary phases with various chemistries
  • Multivariate in silico robustness testing performed to identify the critical method parameters and to set up control strategy for routine applications
  • General specification with suitable working point yielding similar results on six stationary phases
  • Interchangeability of the columns proved in early phase method development

 

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