Determination of the concentration of gilteritinib in human plasma using HPLC
Gilteritinib, an oral inhibitor of FMS‐like tyrosine kinase 3 (FLT3), is a standard treatment for FLT3‐mutated acute myeloid leukemia. We developed a simple HPLC‐UV‐based method for determining the concentration of gilteritinib in human plasma. The analysis requires the extraction of a 200‐μL plasma...
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| Published in | Biomedical chromatography Vol. 35; no. 4; pp. e5028 - n/a |
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| Main Authors | , , , , |
| Format | Journal Article |
| Language | English |
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01.04.2021
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| Abstract | Gilteritinib, an oral inhibitor of FMS‐like tyrosine kinase 3 (FLT3), is a standard treatment for FLT3‐mutated acute myeloid leukemia. We developed a simple HPLC‐UV‐based method for determining the concentration of gilteritinib in human plasma. The analysis requires the extraction of a 200‐μL plasma sample and the precipitation of proteins by solid‐phase extraction. Gilteritinib was isocratically separated within 10 min using a mobile phase of acetonitrile:0.5% monopotassium phosphate (KH2PO4, pH 3.5, 28:72, v/v) on a Capcell Pack C18 MG II (250 × 4.6 mm) column at a flow rate of 1.0 mL/min and monitored at 250 nm. The calibration curve was found to be linear within a plasma concentration range of 25–2500 ng/mL, with the coefficient of determination (r2) being 0.9997. The coefficients of intra‐day and inter‐day validation were 2.3–3.7 and 1.3–5.2%, respectively. The accuracy and recovery of the assay were −9.6 to 0.1 and >81.8%, respectively. This HPLC‐UV method for determining the plasma concentration of gilteritinib is simple and can be effectively applied to routine drug monitoring. |
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| AbstractList | Gilteritinib, an oral inhibitor of FMS‐like tyrosine kinase 3 (FLT3), is a standard treatment for FLT3‐mutated acute myeloid leukemia. We developed a simple HPLC‐UV‐based method for determining the concentration of gilteritinib in human plasma. The analysis requires the extraction of a 200‐μL plasma sample and the precipitation of proteins by solid‐phase extraction. Gilteritinib was isocratically separated within 10 min using a mobile phase of acetonitrile:0.5% monopotassium phosphate (KH2PO4, pH 3.5, 28:72, v/v) on a Capcell Pack C18 MG II (250 × 4.6 mm) column at a flow rate of 1.0 mL/min and monitored at 250 nm. The calibration curve was found to be linear within a plasma concentration range of 25–2500 ng/mL, with the coefficient of determination (r2) being 0.9997. The coefficients of intra‐day and inter‐day validation were 2.3–3.7 and 1.3–5.2%, respectively. The accuracy and recovery of the assay were −9.6 to 0.1 and >81.8%, respectively. This HPLC‐UV method for determining the plasma concentration of gilteritinib is simple and can be effectively applied to routine drug monitoring. Gilteritinib, an oral inhibitor of FMS‐like tyrosine kinase 3 (FLT3), is a standard treatment for FLT3‐mutated acute myeloid leukemia. We developed a simple HPLC‐UV‐based method for determining the concentration of gilteritinib in human plasma. The analysis requires the extraction of a 200‐μL plasma sample and the precipitation of proteins by solid‐phase extraction. Gilteritinib was isocratically separated within 10 min using a mobile phase of acetonitrile:0.5% monopotassium phosphate (KH 2 PO 4 , pH 3.5, 28:72, v/v) on a Capcell Pack C18 MG II (250 × 4.6 mm) column at a flow rate of 1.0 mL/min and monitored at 250 nm. The calibration curve was found to be linear within a plasma concentration range of 25–2500 ng/mL, with the coefficient of determination ( r 2 ) being 0.9997. The coefficients of intra‐day and inter‐day validation were 2.3–3.7 and 1.3–5.2%, respectively. The accuracy and recovery of the assay were −9.6 to 0.1 and >81.8%, respectively. This HPLC‐UV method for determining the plasma concentration of gilteritinib is simple and can be effectively applied to routine drug monitoring. Gilteritinib, an oral inhibitor of FMS-like tyrosine kinase 3 (FLT3), is a standard treatment for FLT3-mutated acute myeloid leukemia. We developed a simple HPLC-UV-based method for determining the concentration of gilteritinib in human plasma. The analysis requires the extraction of a 200-μL plasma sample and the precipitation of proteins by solid-phase extraction. Gilteritinib was isocratically separated within 10 min using a mobile phase of acetonitrile:0.5% monopotassium phosphate (KH PO , pH 3.5, 28:72, v/v) on a Capcell Pack C18 MG II (250 × 4.6 mm) column at a flow rate of 1.0 mL/min and monitored at 250 nm. The calibration curve was found to be linear within a plasma concentration range of 25-2500 ng/mL, with the coefficient of determination (r ) being 0.9997. The coefficients of intra-day and inter-day validation were 2.3-3.7 and 1.3-5.2%, respectively. The accuracy and recovery of the assay were -9.6 to 0.1 and >81.8%, respectively. This HPLC-UV method for determining the plasma concentration of gilteritinib is simple and can be effectively applied to routine drug monitoring. Gilteritinib, an oral inhibitor of FMS-like tyrosine kinase 3 (FLT3), is a standard treatment for FLT3-mutated acute myeloid leukemia. We developed a simple HPLC-UV-based method for determining the concentration of gilteritinib in human plasma. The analysis requires the extraction of a 200-μL plasma sample and the precipitation of proteins by solid-phase extraction. Gilteritinib was isocratically separated within 10 min using a mobile phase of acetonitrile:0.5% monopotassium phosphate (KH2 PO4 , pH 3.5, 28:72, v/v) on a Capcell Pack C18 MG II (250 × 4.6 mm) column at a flow rate of 1.0 mL/min and monitored at 250 nm. The calibration curve was found to be linear within a plasma concentration range of 25-2500 ng/mL, with the coefficient of determination (r2 ) being 0.9997. The coefficients of intra-day and inter-day validation were 2.3-3.7 and 1.3-5.2%, respectively. The accuracy and recovery of the assay were -9.6 to 0.1 and >81.8%, respectively. This HPLC-UV method for determining the plasma concentration of gilteritinib is simple and can be effectively applied to routine drug monitoring.Gilteritinib, an oral inhibitor of FMS-like tyrosine kinase 3 (FLT3), is a standard treatment for FLT3-mutated acute myeloid leukemia. We developed a simple HPLC-UV-based method for determining the concentration of gilteritinib in human plasma. The analysis requires the extraction of a 200-μL plasma sample and the precipitation of proteins by solid-phase extraction. Gilteritinib was isocratically separated within 10 min using a mobile phase of acetonitrile:0.5% monopotassium phosphate (KH2 PO4 , pH 3.5, 28:72, v/v) on a Capcell Pack C18 MG II (250 × 4.6 mm) column at a flow rate of 1.0 mL/min and monitored at 250 nm. The calibration curve was found to be linear within a plasma concentration range of 25-2500 ng/mL, with the coefficient of determination (r2 ) being 0.9997. The coefficients of intra-day and inter-day validation were 2.3-3.7 and 1.3-5.2%, respectively. The accuracy and recovery of the assay were -9.6 to 0.1 and >81.8%, respectively. This HPLC-UV method for determining the plasma concentration of gilteritinib is simple and can be effectively applied to routine drug monitoring. |
| Author | Yasui, Hiroshi Yasu, Takeo Sugi, Tomiyuki Hagihara, Masao Momo, Kenji |
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| Cites_doi | 10.1016/S1470-2045(17)30416-3 10.1111/cas.13749 10.1007/s40262-020-00888-w 10.1056/NEJMoa1902688 10.2147/DDDT.S243760 |
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| References | 2020; 59 2018 2017; 18 2018; 109 2020; 2020 2019; 381 2020 e_1_2_8_3_1 e_1_2_8_2_1 e_1_2_8_5_1 e_1_2_8_4_1 e_1_2_8_7_1 e_1_2_8_6_1 e_1_2_8_8_1 |
| References_xml | – volume: 18 start-page: 1061 year: 2017 end-page: 1075 article-title: Selective inhibition of FLT3 by gilteritinib in relapsed or refractory acute myeloid leukaemia: A multicentre, first‐in‐human, open‐label, phase 1‐2 study publication-title: The Lancet Oncology – volume: 109 start-page: 3235 year: 2018 end-page: 3244 article-title: Clinical profile of gilteritinib in Japanese patients with relapsed/refractory acute myeloid leukemia: An open‐label phase 1 study publication-title: Cancer Science – volume: 381 start-page: 1728 year: 2019 end-page: 1740 article-title: Gilteritinib or chemotherapy for relapsed or refractory FLT3‐mutated AML publication-title: New England Journal of Medicine – year: 2018 – volume: 2020 start-page: 2061 year: 2020 end-page: 2067 article-title: An LC‐MS/MS bioanalytical assay for the determination of gilteritinib in rat plasma and application to a drug‐drug interaction study publication-title: Drug Design, Development and Therapy – volume: 59 start-page: 1273 year: 2020 end-page: 1290 article-title: Pharmacokinetic profile of gilteritinib: A novel FLT‐3 tyrosine kinase inhibitor publication-title: Clinical Pharmacokinetics – year: 2020 – ident: e_1_2_8_5_1 – ident: e_1_2_8_3_1 doi: 10.1016/S1470-2045(17)30416-3 – ident: e_1_2_8_6_1 doi: 10.1111/cas.13749 – ident: e_1_2_8_2_1 doi: 10.1007/s40262-020-00888-w – ident: e_1_2_8_4_1 doi: 10.1056/NEJMoa1902688 – ident: e_1_2_8_8_1 – ident: e_1_2_8_7_1 doi: 10.2147/DDDT.S243760 |
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| Title | Determination of the concentration of gilteritinib in human plasma using HPLC |
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