A Simple HPLC-UV Method for Ivosidenib Determination in Human Plasma
1Department of Medicinal Therapy Research, Pharmaceutical Education and Research Center, Meiji Pharmaceutical University, 2-522-1, Noshio, Kiyose, Tokyo 204-8588, Japan.
A new HPLC-UV method accurately quantifies ivosidenib in plasma, aiding therapeutic drug monitoring for acute myeloid leukemia (AML) patients and potentially reducing toxicity risks.
Area of Science:
- Analytical Chemistry
- Pharmacology
- Clinical Chemistry
Background:
- Ivosidenib treats acute myeloid leukemia (AML) with IDH1 mutations.
- Elevated ivosidenib levels correlate with QT interval prolongation, a potential cardiac risk.
- Therapeutic drug monitoring (TDM) can optimize ivosidenib treatment efficacy and safety.
Purpose of the Study:
- To develop and validate a high-performance liquid chromatography-ultraviolet (HPLC-UV) method for quantifying ivosidenib in human plasma.
- To provide a reliable and accessible method for TDM of ivosidenib.
Main Methods:
- Plasma samples underwent protein precipitation with acetonitrile.
- Chromatographic separation utilized a reversed-phase column and an isocratic mobile phase.
- Ultraviolet detection was performed at 245 nm.
Main Results:
- The HPLC-UV method demonstrated linearity over a concentration range of 0.25-20 μg/mL (r² = 0.99999).
- Assay precision and accuracy were within acceptable limits (intra-day/inter-day precision: 1.20-8.04%/0.69-4.20%; accuracy: -2.00% to 1.93%).
- High recovery rates (>91.2%) confirmed method efficiency.
Conclusions:
- The developed HPLC-UV method is effective and suitable for quantifying ivosidenib in human plasma.
- This simple, cost-effective assay can facilitate broader ivosidenib monitoring, especially in labs without LC-MS/MS.
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