Development and Validation of Valganciclovir and its Active Metabolite Ganciclovir Determination in Human Plasma by HPLC-MS/MS Method

Autor: T. N. Komarov, I. E. Shohin, M. A. Tokareva, O. A. Archakova, D. S. Bogdanova, A. V. Aleshina, N. S. Bagaeva, V. V. Davydanova
Jazyk: ruština
Rok vydání: 2021
Předmět:
Zdroj: Разработка и регистрация лекарственных средств, Vol 10, Iss 1, Pp 120-128 (2021)
Druh dokumentu: article
ISSN: 2305-2066
2658-5049
DOI: 10.33380/2305-2066-2021-10-1-120-128
Popis: Introduction. Currently, physicochemical methods of quantification are actively used to determine the content of drugs in biological fluids. High-performance liquid chromatography with various detection methods is particularly widespread. One of the most difficult practical tasks is the chromatographic separation of so-called poorly retained compounds – drug substances poorly retained on the chromatographic column. Valganciclovir and Ganciclovir are among such substances.Aim. The aim of this study is to develop a method for valganciclovir and ganciclovir in human plasma by high performance liquid chromatography with tandem mass-spectrometry (HPLC-MS/MS) for pharmacokinetic studies.Materials and methods. Determination of valganciclovir and ganciclovir in plasma by HPLC-MS/MS. The samples were processed by acetonitrile protein precipitation.Results and discussion. This method was validated by next parameters: selectivity, matrix effect, calibration curve, accuracy, precision, recovery, lower limit of quantification, carry-over and stability.Conclusion. The method of the determination of valganciclovir and ganciclovir in human plasma was developed and validated by HPLC-MS/MS. The linearity in plasma sample was achieved in the concentration range of 5.00–1000.00 ng/ml for valganciclovir and 50.00–10000.00 ng/ml for ganciclovir. Method could be applied to valganciclovir and ganciclovir determination in plasma for PK and BE studies.
Databáze: Directory of Open Access Journals
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