Computer-assisted chiral HPLC method development for ozanimod on polysaccharide- based chiral stationary phases: possibilities and limitations DOI Creative Commons
Elek Ferencz, Zoltán‐István Szabó, Arnold Zöldhegyi

и другие.

Research Square (Research Square), Год журнала: 2024, Номер unknown

Опубликована: Авг. 23, 2024

Abstract In this study, a direct high performance liquid chromatography method was developed to determine the enantiomeric purity of immunomodulatory drug, ozanimod. A systematic development process followed, incorporating risk assessment, identification critical analytical procedure parameters (APP), initial screening stationary phases, and software-assisted optimization parameters. Eight different polysaccharide-based chiral columns (Lux i-Amylose-1, Lux Amylose-2, Chiralpak AD, Chiralcel OD, Cellulose-1, Cellulose-2, Cellulose-3, Cellulose-4) were selected assess separation enantiomers under polar organic elution mode. The most promising results obtained using methanol (MeOH)-2-propanol (IPA) mixture on AD column. Following this, modeling conducted DryLab software optimize conditions, including isocratic eluent composition (%IPA in MeOH), temperature, flow rate. Baseline achieved within fifteen minutes optimized parameters: column thermostated at 10°C, mobile phase MeOH:IPA:diethylamine (DEA), 70:30:0.1 (v/v/v), delivered rate 0.8 mL/min. validated according International Council Harmonization guideline Q2(R2) for impurity determination ozanimod samples. Additionally, in silico robustness testing tolerance limits their impact enantioresolution. Our findings demonstrate utility DryLab, typically employed reversed-phase achiral separations, optimizing methods even software's limitations purpose are also discussed.

Язык: Английский

Comprehensive two-step supercritical fluid extraction for green isolation of volatiles and phenolic compounds from plant material DOI Creative Commons
Veronika Pilařová, Kateřina Plachká,

Diana Herbsová

и другие.

Green Chemistry, Год журнала: 2024, Номер 26(11), С. 6480 - 6489

Опубликована: Янв. 1, 2024

A comprehensive two-step supercritical extraction using green solvents allows the of non-polar and polar analytes within one run in two consecutive steps.

Язык: Английский

Процитировано

8
Advances in Therapeutic Peptides Separation and Purification DOI Creative Commons
Othman Al Musaimi, Da’san M. M. Jaradat

Separations, Год журнала: 2024, Номер 11(8), С. 233 - 233

Опубликована: Июль 29, 2024

Peptides are gaining prominence in various fields, including the pharmaceutical industry. To meet regulatory requirements, they must achieve a certain purity threshold to ensure safe administration. Numerous purification technologies have been employed purify peptides, aiming reduce cost and time while being sustainable efficient. These include chromatography, magnetic nanoparticles, isoelectric focusing, membrane filtration. The physicochemical properties of peptides main driving element behind these technologies. While chromatographic separation remains gold standard for peptide purification, with models predict elution behaviors other demonstrated their capability performance established methodologies, better productivity reduced cost. This opens door further investigational studies assess outcomes potentially introduce new techniques purification. In this review, we examine terms efficiency ability sustainability concluding remarks an outlook on future advancements.

Язык: Английский

Процитировано

7
Kernel-based reliability potential to assist QSPR prediction and system transfer of SFC−MS retention time DOI Creative Commons
Viviana Consonni, Cristian Rojas,

Jessica Guerrero

и другие.

Chemometrics and Intelligent Laboratory Systems, Год журнала: 2025, Номер unknown, С. 105435 - 105435

Опубликована: Май 1, 2025

Язык: Английский

Процитировано

0
Possibilities and limitations of computer assisted chiral HPLC method development for ozanimod on polysaccharide based chiral stationary phases DOI Creative Commons
Elek Ferencz, Zoltán‐István Szabó, Arnold Zöldhegyi

и другие.

Scientific Reports, Год журнала: 2024, Номер 14(1)

Опубликована: Ноя. 5, 2024

In this study, a direct HPLC method was developed to determine the enantiomeric purity of immunomodulatory drug, ozanimod. A systematic development process followed, incorporating risk assessment, identification critical analytical procedure parameters, initial screening stationary phases, and software-assisted optimization parameters. Eight different polysaccharide-based chiral columns were selected assess separation enantiomers under polar organic elution mode. The most promising results obtained using methanol:2-propanol mixture on amylose-based Chiralpak AD column. Following this, modeling conducted DryLab software optimize conditions, including isocratic eluent composition, temperature, flow rate. Baseline achieved within fifteen minutes optimized parameters: column thermostated at 10 °C, mobile phase methanol:2-propanol: diethylamine, 70:30:0.1 (v/v/v %), delivered rate 0.8 mL/min. validated according current guidelines in silico robustness testing tolerance limits for parameters their impact enantioresolution. Our findings demonstrate utility DryLab, typically employed reversed-phase achiral separations, optimizing methods even Limitations approach are also highlighted.

Язык: Английский

Процитировано

1
Computer-assisted chiral HPLC method development for ozanimod on polysaccharide- based chiral stationary phases: possibilities and limitations DOI Creative Commons
Elek Ferencz, Zoltán‐István Szabó, Arnold Zöldhegyi

и другие.

Research Square (Research Square), Год журнала: 2024, Номер unknown

Опубликована: Авг. 23, 2024

Abstract In this study, a direct high performance liquid chromatography method was developed to determine the enantiomeric purity of immunomodulatory drug, ozanimod. A systematic development process followed, incorporating risk assessment, identification critical analytical procedure parameters (APP), initial screening stationary phases, and software-assisted optimization parameters. Eight different polysaccharide-based chiral columns (Lux i-Amylose-1, Lux Amylose-2, Chiralpak AD, Chiralcel OD, Cellulose-1, Cellulose-2, Cellulose-3, Cellulose-4) were selected assess separation enantiomers under polar organic elution mode. The most promising results obtained using methanol (MeOH)-2-propanol (IPA) mixture on AD column. Following this, modeling conducted DryLab software optimize conditions, including isocratic eluent composition (%IPA in MeOH), temperature, flow rate. Baseline achieved within fifteen minutes optimized parameters: column thermostated at 10°C, mobile phase MeOH:IPA:diethylamine (DEA), 70:30:0.1 (v/v/v), delivered rate 0.8 mL/min. validated according International Council Harmonization guideline Q2(R2) for impurity determination ozanimod samples. Additionally, in silico robustness testing tolerance limits their impact enantioresolution. Our findings demonstrate utility DryLab, typically employed reversed-phase achiral separations, optimizing methods even software's limitations purpose are also discussed.

Язык: Английский

Процитировано

0