A quantitative method for the determination of bosutinib in human plasma using high‐performance liquid chromatography and ultraviolet detection

Abstract

The proposed HPLC-UV method was successfully applied as an assay to detect bosutinib in human plasma.

Simultaneous quantification of dasatinib, nilotinib, bosutinib, and ponatinib using high‐performance liquid chromatography–Photodiode array detection

“…Good extraction recoveries (80.7%–98.5%) were obtained for the four TKIs. This study demonstrated a recovery rate (Table 3) similar to or higher than those reported in previous studies using similar SPE methods (recovery rates of 74%–76% for dasatinib, 20 72%–78% for nilotinib, 20 84%–85% for bosutinib, 25 and 78%–88% for ponatinib 19 ). Although the SPE pretreatment method was the same as the one used in previous studies, our use of 2% phosphoric acid as a dilution solvent for the serum samples may have contributed to the higher recovery rate.…”

“…The accuracy and precision values for dasatinib (2–500 ng/ml) were within ±14.3% and 17.9%, nilotinib values (100–5000 ng/ml) were within ±14.4% and 7.3%, bosutinib values (10–500 ng/ml) were within ±12.8% and 7.3%, and ponatinib values (10–500 ng/ml) were within ±11.9% and 10.1%, respectively. On the other hand, the accuracy and precision values in the previous single analyte assays for dasatinib (10–1000 ng/ml) were within ±4.1% and 15.8%, 20 the values for nilotinib (10–5000 ng/ml) were within ±10.5% and 10.4%, 20 the values for bosutinib (25–1500 ng/ml) were within ±10.2% and 8.7%, 25 and the values for ponatinib (1–250 ng/ml) were within ±9.0% and 10.8%. 19 The simultaneous measurement of multiple drugs and concentration range of the calibration curves resulted in similar or higher accuracy and precision than previous assays; however, they all met the criteria of FDA's validation guideline.…”

“…To the best of our knowledge, this is the first report on an efficient HPLC‐PDA analytical method for simultaneous quantification of dasatinib, nilotinib, bosutinib, and ponatinib in human serum. Although several methods have been developed for the quantification of each TKI by HPLC literature, 14 , 19 , 20 , 21 , 22 , 23 , 24 , 25 and simultaneous quantification of TKIs with other analytes by LC–MS/MS has also been reported, 14 , 15 , 16 , 17 , 18 this method is more efficient. This simultaneous measurement has the advantage that TDM can be performed quickly in the same measurement run, without the need to change the HPLC conditions for each drug when measuring the concentrations of several patients administered with four different TKIs.…”

“…In addition, high‐performance liquid chromatography (HPLC) assays that quantify each TKI separately have already been reported in literature. 14 , 19 , 20 , 21 , 22 , 23 , 24 , 25 Efficient simultaneous quantification of second‐generation and later‐generation TKIs using HPLC with photodiode array (PDA) detectors would improve TDM; however, such a method for dasatinib, nilotinib, bosutinib, and ponatinib has not yet been developed.…”

“…Although multicenter studies on liquid chromatography–tandem mass spectrometry (LC–MS/MS) assays for multiple TKIs have been conducted, 14–18 clinical use remains challenging. In addition, high‐performance liquid chromatography (HPLC) assays that quantify each TKI separately have already been reported in literature 14,19–25 . Efficient simultaneous quantification of second‐generation and later‐generation TKIs using HPLC with photodiode array (PDA) detectors would improve TDM; however, such a method for dasatinib, nilotinib, bosutinib, and ponatinib has not yet been developed.…”