Construction of a Simplex Search Framework for the Development of a New Specific and Robust Stability-Indicating Reversed-Phase High-Performance Liquid Chromatography Assay: Application for the Stability of a Peptide-Based Telomerase Vaccine

IF 2.8 3区工程技术 Q2 CHEMISTRY, ANALYTICAL

Journal of separation science Pub Date : 2025-03-08 DOI:10.1002/jssc.70111

Claire Andre, Lydie Lethier, Yves Claude Guillaume

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Abstract

In this work, a novel mathematical algorithm was described for the development of a high-performance liquid chromatography (HPLC) stability-indicating assay. This approach was applied for the stability study of a universal cancer peptide-based telomerase vaccine constituted of a mixture of two peptides. With only 18 experiments, the optimum HPLC gradient conditions were determined using a computer-assisted design of experiments—simplex algorithm software. In addition, the separation on the chromatogram of the isoaspartate peptide degradation product with the active pharmaceutical ingredients was achieved. This HPLC method was validated as per the International Committee on Harmonization guidelines. It was shown that this vaccine was physicochemical stable for 2 months when stored in borosilicate glass vials at −20°C and no formation of isoaspartate peptide was detected. In addition, this vaccine was stable for up to 10 h at 4°C or room temperature after thawing the samples. No impact of potential temperature excursion on the vaccine concentration in the borosilicate glass vial was observed.

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来源期刊

Journal of separation science 化学-分析化学

CiteScore

6.30

自引率

16.10%

发文量

408

审稿时长

1.8 months

期刊介绍： The Journal of Separation Science (JSS) is the most comprehensive source in separation science, since it covers all areas of chromatographic and electrophoretic separation methods in theory and practice, both in the analytical and in the preparative mode, solid phase extraction, sample preparation, and related techniques. Manuscripts on methodological or instrumental developments, including detection aspects, in particular mass spectrometry, as well as on innovative applications will also be published. Manuscripts on hyphenation, automation, and miniaturization are particularly welcome. Pre- and post-separation facets of a total analysis may be covered as well as the underlying logic of the development or application of a method.