Please use this identifier to cite or link to this item: http://dspace.nuph.edu.ua/handle/123456789/19865
Title: Development and validation of LC-MS/MS method for estimation of urocarb in human plasma
Authors: Drapak, I. V.
Драпак, І. В.
Zimenkovsky, B. S.
Зіменковський, Б. С.
Perekhoda, L. O.
Перехода, Л. О.
Kovalenko, S. M.
Коваленко, С. М.
Logoyda, L.
Keywords: LC-MS/MS;urocarb;human plasma;validation;pharmacokinetic studies
Issue Date: 2019
Publisher: International Journal of Applied Pharmaceutics
Bibliographic description (Ukraine): Development and validation of LC-MS/MS method for estimation of urocarb in human plasma / I. V. Drapak, B. S. Zimenkovsky, L. O. Perekhoda, S. M. Kovalenko, L. Logoyda // Int J App Pharm. - 2019. - Vol. 11. - Р. 125-130.
Abstract: The total chromatographic run time was 2.0 min and the elution of urocarb and IS (etomidate) occurred at ~1.53 and 1.67 min, respectively. A linear response function was established at 1-100 ng/ml for urocarb and etomidate in human plasma. The % mean recovery for urocarb in LQC, MQC and HQC was 104.1 %, 100.0 % and 97.4 %. The lowest concentration with the RSD<20% was taken as LLOQ and was found to be 1.03 ng/ml for urocarb. The within-run coefficients of variation ranged between 0.271 % and 0.478 % for urocarb. The within-run percentages of nominal concentrations ranged between 99.12 % and 100.21 % for urocarb. The between-run coefficients of variation ranged between 0.388 % and 0.601 % for urocarb. The between-run percentages of nominal concentrations ranged between 98.78 % and 101.11 % for urocarb.
Description: A highly sensitive, specific, reproducible, rapid and high-throughput LC-MS/MS assay was developed and validated to quantify urocarb in human plasma as per the regulatory guidelines. Due to the sensitivity of the developed method, it can be applied to the monitoring of plasma levels in the analysis of drug in preclinical and clinical pharmacokinetic studies. All the parameters and results were found within the acceptance limit as given in the validation protocol.
URI: http://dspace.nuph.edu.ua/handle/123456789/19865
Appears in Collections:Наукові публікації кафедри медичної хiмiї

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