1Department of Quality Assurance, Gahlot Institute of Pharmacy, Plot 59, Sector 14, Kopar Khairane, Navi Mumbai, Maharashtra, 400709
2The Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Kharghar, Navi Mumbai
The primary goal of this research was to create a therapeutic drug monitoring (TDM) approach for the oldest anticancer medication, 5-fluorouracil (5FU).
We employed a Plasma matrix for analyte extraction through protein precipitation. Chromatographic separation of the analyte with the internal standard, 5-bromouracil (5BU), was carried out using a Phenomenex Luna C18 150*4.6mm 5um analytical column with an isocratic program. Gimeracil, which serves as a DPD enzyme inhibitor, was used to enhance the stability of 5FU in blood. The calibration curve for 5-fluorouracil was linear (r2 ≥ 0.99) from a range of 0.2μg/ml to 10μg/ml. The validation of the method was conducted following the bioanalytical method guidelines outlined by ICH and FDA in 2022.
The method has been successfully developed and validated as a therapeutic drug monitoring (TDM) service to accurately determine the level of 5FU concentration in patients with gastric conditions, ensuring the specificity, sensitivity, and reliability of the method.
Method development, 5-fluorouracil, 5-bromouracil, Therapeutic drug monitoring, Gimeracil, Bioanalytical method validation
