Literature

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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 I, II, III 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.

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

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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.

Linear solvent strength model on porous graphitic carbon stationary phase using high temperature liquid chromatographic method for allopurinol related substances analysis

Barnabás Soós, Krisztián Horváth, Róbert Kormány
Journal of Pharmaceutical and Biomedical Analysis, 245, 1 August, 1-6 (2024)

Keywords: Allopurinol, High temperature liquid chromatography, Porous graphitic carbon, DryLab, Method development, Retention modeling

http://doi.org/10.1016/j.jpba.2024.116200

Highlights

Allopurinol and its Ph.Eur. impurities are analyzed with porous graphitic carbon.
The retention behavior is different than in reversed phase separations.
Linear solvent strength (LSS) theory can be used for method development.
All compounds can be separated in 6 min with baseline resolution.
LSS-based method development software are efficient for PGC phases.

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

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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.

Application of chiral stationary phases for the separation of vitamin A acetate isomers

Nicole Schräder et. al
Journal of Chromatography A, 1718, 15 March, 1-8 (2024)

Keywords: Chiral stationary phases, High performance liquid chromatography, Vitamin A acetate isomers, Cellulose stationary phases, Amylose stationary phases

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http://doi.org/10.1016/j.chroma.2024.464710

Highlights

Vitamin A isomer separation in RP mode on CSPs is superior to existing methods.
Screening of CSPs provides ideal stationary phase.
Molecular planarity recognition is the predominant retention mechanism.
Method optimization and considerations for a better suited stationary phase design.

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

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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.

Retention modeling of therapeutic peptides in sub-/supercritical fluid chromatography

Jonas Neumann, Sebastian Schmidtsdorff, Alexander H. Schmidt, Maria K. Parr
Separation Science Plus, 7, 11 February, 1-12 (2024)

Keywords: Chromatographic modeling, Retention time prediction, Ternary composition, Therapeutic peptides

PDF
http://doi.org/10.1002/sscp.202300239

Abstract

Chromatographic modeling software packages are valuable tools during method optimization steps. These are well established for reversed‐phase applications utilizing retention time (RT) prediction to optimize separations and receive robust methods, which is of high interest for the analysis of pharmaceuticals. In contrast to liquid chromatography, the knowledge of RT prediction in supercritical fluid chromatography is limited to a manageable number of studies.

This study uses the software DryLab to predict the RTs of the peptides bacitracin (Bac), colistin, tyrothricin (Tyro), and insulin analogs. Gradient time, column temperature, and the ternary composition (terC) of carbon dioxide, methanol (MeOH), and acetonitrile (ACN) in the gradient elution are varied in a feasibility approach using a neutral (Viridis BEH) and an amino‐derivatized aromatic (Torus 2‐PIC) stationary phase. In the second part, chromatographic optimization is performed in silico through gradient adjustments to optimize the separation of the fingerprint of Bac. The final gradient method utilizes a Viridis BEH column (100 × 3.0 mm, 1.7 μm), carbon dioxide, and a modifier consisting of ACN/MeOH/water/methanesulfonic acid (60:40:2:0.1, v:v:v:v). In addition, changes in the retention order of Tyro compounds with the proportion of the terC in combination with a Torus Diol column are investigated.

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