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.

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

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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

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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

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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

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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

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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.

Automated UHPLC separation of 10 pharmaceutical compounds using software-modeling

A.Zöldhegyi, H.-J.Rieger, I.Molnár, L.Fekhretdinova
J Pharm Biomed Anal., 156, 15 July, 379-388 (2018)

Keywords: Automated resolution modeling, In-silico method development, Reduction of human error in (U)HPLC, Data integrity, Time efficiency, DryLab

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http://doi.org/10.1016/j.jpba.2018.03.039

Human mistakes are still one of the main reasons of underlying regulatory affairs that in a compliance with FDA's Data Integrity and Analytical Quality by Design (AQbD) must be eliminated. To develop smooth, fast and robust methods that are free of human failures, a state-of-the-art automation was presented. For the scope of this study, a commercial software (DryLab) and a model mixture of 10 drugs were subjected to testing. Following AQbD-principles, the best available working point was selected and conformational experimental runs, i.e. the six worst cases of the conducted robustness calculation, were performed. Simulated results were found to be in excellent agreement with the experimental ones, proving the usefulness and effectiveness of an automated, software-assisted analytical method development.

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