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Evaluation of Retention Range of Extractables Under Linear Gradient Conditions for Reversed-Phase Chromatographic Considerations and Requirements in Extractables Analytical Methods for Chemical Characterization of Medical Devices

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Abstract

Chromatographic considerations and requirements in developing general RPLC profiling analytical methods for eluting complex medical device extracts are investigated using linear gradient conditions, based on Abraham general solvation model. The focus of the study is not on the development of a specific RPLC method for a particular extract, but on the general considerations and requirements in retention and peak capacity optimization in the separation of complex unknown extracts, possibly with a high number of components and a wide-ranging diversity in hydrophobicity, volatility, and molecular weight (MW). The published representative RPLC gradient conditions, together with nearly 2000 selected compounds as a representation of potential extractables, are used to correlate the gradient retention time and hydrophobicity (\(\mathrm{Log}{P}_{o/w}\)) of extractables, both calculated by Abraham solvation model. The hydrophobicity range that each gradient separation condition of defined run time can cover is determined, and the \(\mathrm{Log}{P}_{o/w}\) values, at which late-eluting and early-eluting issues occur, are computed as well. It is concluded that the complex medical device extraction samples should be separated by RPLC linear gradient elution, and retention time and peak capacity should be optimized to retain and resolve all extractables components for the discovery of extractables components in the sample.

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Li, J. Evaluation of Retention Range of Extractables Under Linear Gradient Conditions for Reversed-Phase Chromatographic Considerations and Requirements in Extractables Analytical Methods for Chemical Characterization of Medical Devices. Chromatographia 85, 755–771 (2022). https://doi.org/10.1007/s10337-022-04185-5

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