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@proceedings{2335200, author = {Krejčířová, Eva and Pelcová, Marta and Juřica, Jan and Glatz, Zdeněk}, keywords = {Alpelisib, plasma, HPLC, fluorescence, extraction}, language = {eng}, title = {HPLC-FLD Method Development for the Determination of Alpelisib in Human Plasma}, year = {2023} }
TY - CONF ID - 2335200 AU - Krejčířová, Eva - Pelcová, Marta - Juřica, Jan - Glatz, Zdeněk PY - 2023 TI - HPLC-FLD Method Development for the Determination of Alpelisib in Human Plasma KW - Alpelisib, plasma, HPLC, fluorescence, extraction N2 - Alpelisib (ALP) is a selective phosphatidylinositol 3-kinase (PI3K) inhibitor approved for breast cancer treatment. Dysregulation of the PI3K signal pathway is involved in progression of cancer and is therefore a target for antineoplastic therapy. Another indication approved only in the United States is the treatment of severe manifestations of PIK3CA-Related Overgrowth Spectrum, including venous malformations. ALP exposure shows considerable inter-individual variability and adverse effects and therefore therapeutic drug monitoring (TDM) is beneficial. Fluorescence detection is a more affordable alternative to LC-MS/MS methods and provides sufficient sensitivity for TDM and pharmacokinetic profiling. After optimizing the HPLC-FLD separation conditions, a suitable liquid-liquid extraction procedure was tested. The highest extraction yield was obtained with a mixture of dichloromethane-isopropanol, 9:1 (v/v). The method was validated according to the European Medicines Agency guidelines. The developed HPLC-FLD method was applied to determine ALP in patient plasma samples. The obtained concentrations were within the chosen calibration range (10–1000 ng/mL). This method is sensitive enough for the TDM of ALP in human plasma even for non-standard dosing schedules (e.g. off label use, children). ER -
KREJČÍŘOVÁ, Eva, Marta PELCOVÁ, Jan JUŘICA a Zdeněk GLATZ. \textit{HPLC-FLD Method Development for the Determination of Alpelisib in Human Plasma}. 2023.
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