Features of the selection of operations of preparation of blood plasma samples for the chromatographic analysis of drugs
Abstract
Reversed-phase high-performance liquid chromatography (RP HPLC) with spectrophotometric/mass spectrometric detection is widely used to determine drug products (DP) in pharmacokinetic studies and to assess the bioequivalence of drugs. The increasing diversity of DP structures complicates the development of bioanalytical methods for determining the content of DP in biological matrices. The most common matrix in practical work is human blood plasma, which has a complex composition of endogenous substances. The choice and optimization of sample preparation operations (or their combinations) is still most often carried out based on the most general ideas about the nature of the determined compounds. This leads to a large consumption of time, which could be minimized if the sample preparation operations would be related to the physicochemical characteristics of the analytes.
In this study, as a result of systematization of the known methods for preparing blood plasma samples for the determination of DP, the possibility of choosing such methods based on certain physicochemical properties and biochemical characteristics of the target analytes, primarily their hydrophobicity factors, the degree plasma protein binding of drugs, and solubility in water, is considered. Based on a comparison of the original experimental and literature data, an approach for choosing a sample preparation method for determining the target analyte in blood plasma based on properties (hydrophobicity factor logP and degree of plasma protein binding of drugs) of the analyte was described.
It has been shown that the deproteinization of samples using ultracentrifuge filters is possible only for those compounds, the degree of protein binding of which is not higher than 50%. The log P value determines the possibility of using the distribution variant of liquid-liquid extraction as a method of sample preparation. At the same time, hydrophobicity factor values do not affect the choice of protein precipitation operation, e.g., this method of sample preparation is suitable for both lipophilic and hydrophilic analytes.
The identified features of the procedures for preparing blood plasma samples for chromatographic analysis allow to optimize the development and validation of bioanalytical methods used in clinical trials.
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References
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