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 UHPLC method development and optimization for the determination of albendazole and its related substances

Elek Ferencz et. al
J. Pharm. Biomed. Anal., 203, 5 September, 1-11 (2021)

Keywords: Drylab, Retention modelling, AQbD, Experimental design, Method validation, In silico robustness testing

PDF
http://doi.org/10.1016/j.jpba.2021.114203

Highlights

• Computer aided chromatographic method development for the simultaneous determination of albendazole and its related substances.

• Optimization was realized using experimental design-based approach.

• Alternative to replace an underperforming European Pharmacopoeia method.

• In silico robustness testing and retention modelling performed by DryLab software.

• After validation, method applicability was tested on commercial tablet formulation.


Superheated reversed phase chromatography with ultrashort columns for the analysis of therapeutic proteins

Balázs Bobály, Alex Keresztfalvi, Thomas Gräber, Maria Anna Schwarz
J. Pharm. Biomed. Anal., 203, 5 September, 1-7 (2021)

Keywords: Superheated reversed phase chromatography, Non-covalent protein complexes, Ultrashort column, On-column degradation, Bispecific

PDF
http://doi.org/10.1016/j.jpba.2021.114162

Highlights

  • Therapeutic protein complexes separated at superheated conditions.
  • Complex dissociation is complete at superheated conditions.
  • On-column degradation can be limited by fast gradients and ultrashort columns.

New wide-pore superficially porous stationary phases with low hydrophobicity applied for the analysis of monoclonal antibodies

Szabolcs Fekete et. al
J. Chromatogr. A, 1642, 12 April, 1-7 (2021)

Keywords: Superficially porous particles, wide-pore, low hydrophobicity, recovery, monoclonal antibody

PDF
http://doi.org/10.1016/j.chroma.2021.462050

Highlights

  • New stationary phases with low hydrophobicity were tested for protein separations
  • The new ES-LH stationary phase showed excellent protein recovery
  • The ES-LH and C1 materials were found to be less retentive than commercial phases
  • The ES-LH phase showed novel selectivity due to its unique surface chemistry

Development of a Fast and Robust UHPLC Method for Apixaban In-Process Control Analysis

Róbert Kormány, Norbert Rácz, Szabolcs Fekete, Krisztián Horváth
Molecules, 3505, 26, 1-8 (2021)

Keywords: Apixaban, Design of Experiments, Liquid Chromatography, Method Development, Quality by Design, Robustness

PDF
http://doi.org/10.3390/molecules26123505

In-process control (IPC) is an important task during chemical syntheses in pharmaceutical industry. Despite the fact that each chemical reaction is unique, the most common analytical technique used for IPC analysis is high performance liquid chromatography (HPLC). Today, the so-called “Quality by Design” (QbD) principle is often being applied rather than “Trial and Error” approach for HPLC method development. The QbD approach requires only for a very few experimental measurements to find the appropriate stationary phase and optimal chromatographic conditions such as the composition of mobile phase, gradient steepness or time (tG), temperature (T), and mobile phase pH. In this study, the applicability of a multifactorial liquid chromatographic optimization software was studied in an extended knowledge space. Using state-of-the-art ultra-high performance liquid chromatography (UHPLC), the analysis time can significantly be shortened. By using UHPLC, it is possible to analyse the composition of the reaction mixture within few minutes. In this work, a mixture of route of synthesis of apixaban was analysed on short narrow bore column (50 × 2.1 mm, packed with sub-2 µm particles) resulting in short analysis time. The aim of the study was to cover a relatively narrow range of method parameters (tG
, T, pH) in order to find a robust working point (zone). The results of the virtual (modeled) robustness testing were systematically compared to experimental measurements and Design of Experiments (DoE) based predictions.


Development of an analytical method for the determination of pimavanserin and its impurities applying analytical quality by design principles as a risk-based strategy

Irena Radić, Mislav Runje, Sandra Babić
J. Pharm. Biomed. Anal., 201, 15 July, 1-11 (2021)

Keywords: Analytical quality by design, Design of experiments, Forced degradation, Impurities, Pimavanserin, UHPLC

http://doi.org/10.1016/j.jpba.2021.114091

Highlights

 

  • A UHPLC method for the assay of pimavanserin and its impurities was developed.
  • Analytical quality by design was applied in the method development.
  • Forced degradation under hydrolytic, oxidative, thermal and photolytic conditions.
  • Significant degradation was observed in acid, base and oxidative conditions.
  • Degradation pathways were assessed in-silico and by UHPLC-qTOF.

 


Integrated analytical workflow for chromatographic profiling and metabolite annotation of a cytotoxic Phorbas amaranthus extract

Bruno S. do Amaral et. al
J. Chromatogr. B, 1174, 1 June, 1-10 (2021)

Keywords: Bioactivity, multi-column screening, chromatographic modeling and simulation, DryLab®, marine natural products

PDF
http://doi.org/10.1016/j.jchromb.2021.122720

Highlights:

  • Phorbas amaranthus extract as natural products library
  • DryLab® software for Design of Experiments in association with scouting systems
  • Sixty-four metabolites chemically characterized by LC-HRMS
  • New metabolites inferred based on Global Natural Product Social Molecular Networking (GNPS)
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