Procedure for determining the validation parameter “Linearity /calibration model”of analytical methodology of quantitative determination of some antihypertensive analyts in biological liquids for pharmacokinetic studies
DOI:
https://doi.org/10.11603/mcch.2410-681X.2018.v0.i2.9141Keywords:
amlodipine, bisoprolol, enalapril, validation, “linearity/calibration model”.Abstract
Introduction. To study the pharmacokinetics of medicines, the most relevant is the development of bioanalytical methods of analysis. However, in order to increase the effectiveness of the pharmacotherapy of any disease, including hypertension, several medicines are prescribed at the same time, or multicomponent medicines are the subject of study, so it is expedient to develop a bioanalytical method for the simultaneous determination of several analytes, and sometimes in the present of their metabolites, in the human plasma.
The aim of the study – to conduct an experimental study of validation parameter “linearity/calibration model” for quantitative determination of amlodipine, bisoprolol and enalapril in human plasma for pharmacokinetic studies.
Research Methods. The bioanalytical method for the determination of amlodipine, bisoprolol and enalapril is based on HPLC/MS/MS analysis of analytes in investigated solutions obtained from plasma samples after preprecipitation of proteins.
Results and Discussion. A linear relationship was found between the concentration and the chromatographic peaks of amlodirine, bisoprolol and enalapril in the range of concentrations of 0.1–10 ng/ml, 0.5–50 ng/ml and 5–500 ng/ml, respectively.
Conclusion. The conclusion regarding the developed methodology according to the validation parameter “linearity/calibration model” is correct.
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