Liquid Chromatography

Kitagawa, Shinya

doi:10.2116/analsci.highlights1909

Cited by 5 publications

(2 citation statements)

References 24 publications

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“…As a whole, stress studies are considered an essential part of the drug development cycle. Among all the sophisticated techniques chromatographic retention assisted mass spectrometry including Q-TOF is considered an excellent tool in characterization of unknown drug-related impurities with high selectivity and sensitivity (Watkins 2020;Chang et al 2018;Kitagawa 2019).…”

Section: Introductionmentioning

confidence: 99%

LC-Q-TOF-MS driven identification of potential degradation impurities of venetoclax, mechanistic explanation on degradation pathway and establishment of a quantitative analytical assay method

2020

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Venetoclax is a selective orally active Bcl-2 protein inhibitor very recently approved by USFDA to treat chronic lymphocytic leukemia and other hematological malignancies. Postmarketing surveillance of any drug depends on its acceptability based on risk to benefit ratio. When risk outweighs the benefits, withdrawal of an already marketed drug is warranted. Presence of impurity is the primary cause of increased risk in a drug substance or drug product. With the discovery of newer molecules, it is of great importance to establish advanced analytical techniques for quantification of the drugs as well as their related impurities to address the prospective regulatory queries even if it is already in the market. In this study, a quantitative analytical assay method has been developed and validated for quantification of venetoclax in presence of its degradation impurities. A stress study was performed to examine the stability of the drug in hydrolytic, oxidative, thermolytic and photolytic environments. Venetoclax was found to be prone to degradation in acidic hydrolytic and oxidative stress conditions. Three new degradation impurities have been identified and characterized with the help of LC-Q-TOF-MS with accurate mass measurement and their putative structures have been proposed. Furthermore, for the first time, a possible degradation pathway has been established with mechanistic explanation. Moreover, the analytical method developed in this study will be of immense help for routine analysis of quality control and stability study samples of venetoclax in industry and research laboratories.

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Section: Introductionmentioning

confidence: 99%

LC-Q-TOF-MS driven identification of potential degradation impurities of venetoclax, mechanistic explanation on degradation pathway and establishment of a quantitative analytical assay method

2020

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“…3 In order to achieve higher partition efficiency including the peak resolution and the stationary phase retention, many hydrostatic and hydrodynamic types of CCC instruments have been developed by a number of researchers. 4 In the hydrodynamic CCC machines, high-speed countercurrent chromatography (HSCCC) mainly including the type-J coil planet centrifuge (CPC) and the cross-axis CPC has been most effective for the separation of various chemical compounds as the best models. 5 These two HSCCC instruments have remarkable rotation mechanisms that in the type-J CPC the coiled column rotates about its own planet axis and revolves around the central sun axis in the same direction, while in the cross-axis CPC the coiled column rotates vertically about its own planet axis while revolving around the central sun axis in a horizontal plane.…”

Section: Introductionmentioning

confidence: 99%

Partition Efficiency of Eccentric Coil for Countercurrent Chromatographic Separation of Proteins Using Small-scale Cross-axis Coil Planet Centrifuge with Circular and Elliptic Cylindrical Columns

et al. 2020

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The partition efficiency of the double-spaced coil for eccentric and toroidal coils on countercurrent chromatographic separation of proteins was evaluated using the small-scale cross-axis coil planet centrifuge (CPC) equipped with circular and elliptic cylindrical columns. Standard cytochrome C, myoglobin and lysozyme samples were used for separation with the 12.5% (w/w) polyethylene glycol 1000 and 12.5% (w/w) dibasic potassium phosphate system. In the circular column, the double-spaced eccentric coil yielded better peak resolution than the double-spaced toroidal coil, and the double-spaced eccentric coil than the single-spaced eccentric coil. In the elliptic column, the double-spaced eccentric coil also produced better peak resolution than the double-spaced toroidal coil, but the single-spaced eccentric coil than the double-spaced eccentric coil. The overall results indicated that the double-spaced eccentric coil for the circular column and the single-spaced eccentric coil for the elliptic column yielded better protein separation using the small-scale cross-axis CPC with aqueous two-phase solvent systems.

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Emerging Analytical Techniques in Forensic Samples

Bhatnagar

Rao

2023

Modern Forensic Tools and Devices

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Liquid Chromatography

Cited by 5 publications

References 24 publications

LC-Q-TOF-MS driven identification of potential degradation impurities of venetoclax, mechanistic explanation on degradation pathway and establishment of a quantitative analytical assay method

LC-Q-TOF-MS driven identification of potential degradation impurities of venetoclax, mechanistic explanation on degradation pathway and establishment of a quantitative analytical assay method

Partition Efficiency of Eccentric Coil for Countercurrent Chromatographic Separation of Proteins Using Small-scale Cross-axis Coil Planet Centrifuge with Circular and Elliptic Cylindrical Columns

Emerging Analytical Techniques in Forensic Samples

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