A strategy for assessing peak purity of pharmaceutical peptides in reversed-phase chromatography methods using two-dimensional liquid chromatography coupled to mass spectrometry. Part I: Selection of columns and mobile phases

Petersson, Patrik; Buckenmaier, Stephan; Euerby, Melvin R.; Stoll, Dwight R.

doi:10.1016/j.chroma.2023.463874

Cited by 8 publications

(2 citation statements)

References 18 publications

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“…Petersson and co-workers published a series of intriguing papers that investigated 43 RPLC columns to establish a column characterization database to help identify backup columns for existing methods and highlight complementary stationary-phase combinations with significant selectivity differences for method development [30,31]. The same group then described strategies for assessing the peak purity of therapeutic peptides, where they focused on the selection of columns and mobile phases [32]. After their developed protocol for column characterization, they established a column characterization database.…”

Section: Reversed-phase Liquid Chromatography (Rplc)mentioning

confidence: 99%

Advances in Therapeutic Peptides Separation and Purification

Al Musaimi,

Jaradat

2024

Separations

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

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Section: Reversed-phase Liquid Chromatography (Rplc)mentioning

confidence: 99%

Advances in Therapeutic Peptides Separation and Purification

Al Musaimi,

Jaradat

2024

Separations

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“…Figure 9 in Part I of this study[15] and Fig.6in this paper show results from the application of the method development workflow in two additional laboratories.Figure 9 in Part I shows chromatograms obtained from a peak purity analysis of a method developed for the peptide [L-Ser5]-GLP2 (1-15) in Laboratory C. In order to evaluate the suggested strategy a sample of [L-Ser5]-GLP2 (1-15) was spiked with 12% of a racemisation product [D-Ser5]-GLP-2(1-15) which coelutes in the method for which peak purity should be assessed. Subsequently retention data from three different gradient slopes were used to…”

mentioning

confidence: 94%

A Strategy for assessing peak purity of pharmaceutical peptides in reversed-phase chromatography methods using two-dimensional liquid chromatography coupled to mass spectrometry. Part II: Development of second-dimension gradient conditions

Stoll

Sylvester

Euerby

et al. 2023

Journal of Chromatography A

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A stability‐indicating method development and validation for the determination of related substances in novel synthetic decapeptide by HPLC

Pawar,

Tivari,

Panchani

et al. 2024

Journal of Peptide Science

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In the present scenario, peptide is an emerging field of research having vast therapeutic applications. Diverse impurities may rise from various stages of the synthesis process and storage of the peptides. Because these contaminants may have an impact on the therapeutic safety and effectiveness of peptides in their approaching applications, they must be identified and carefully monitored. Considering the pharmaceutical importance of the extent of peptides, we were motivated to synthesize a decapeptide and establish a novel gradient reversed‐phase high‐performance liquid chromatography (RP‐HPLC) method for its analysis along with efficient separation of its six related impurities. Different buffers, organic modifiers, and columns were used in the tests for good separation of these impurities. To establish a stability‐indicating method, a stress study was also conducted. The International Conference on Harmonization (ICH) guidelines have been followed for validation of the developed analytical method. The validated method revealed sufficient accuracy, specificity, linearity, robustness, precision, and high sensitivity for its intended use. The proposed method could be appropriate for routine analysis and stability assessment of the decapeptide, which might be useful for further scientific investigation.

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A strategy for assessing peak purity of pharmaceutical peptides in reversed-phase chromatography methods using two-dimensional liquid chromatography coupled to mass spectrometry. Part I: Selection of columns and mobile phases

Cited by 8 publications

References 18 publications

Advances in Therapeutic Peptides Separation and Purification

Advances in Therapeutic Peptides Separation and Purification

A Strategy for assessing peak purity of pharmaceutical peptides in reversed-phase chromatography methods using two-dimensional liquid chromatography coupled to mass spectrometry. Part II: Development of second-dimension gradient conditions

A stability‐indicating method development and validation for the determination of related substances in novel synthetic decapeptide by HPLC

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