Ultra High Performance Liquid Chromatography Method for the Determination of Two Recently FDA Approved TKIs in Human Plasma Using Diode Array Detection

Table 1

Validation data of linear regression of AFA and IBR in human plasma.

Analyte	Regression model	VS	Concentration; (ng/mL)	Trueness	Precision	Accuracy	Extraction efficiency
				Relative bias (%)	Repeatability/; intermediate precision (RSD, %)	β-expectation lower and upper tolerance limits of the relative error (%)	Average recovery (%) (, each level)
AFA	1		5	−0.24	5.60/5.65	[−13.38; 12.90]	88.0 ± 2.2
	2		25	1.31	5.54/4.94	[−9.96; 12.58]
	3		75	0.63	2.70/2.63	[−5.44; 6.71]
	4		125	1.29	2.23/2.42	[−4.52; 7.09]
	5		175	0.56	1.87/1.66	[−3.23; 4.36]
	6		250	−0.25	1.63/1.91	[−4.77; 4.27]
DICLO			250	Internal standard			91 ± 7
IBR	1		5	−1.21	5.83/5.22	[−12.96; 10.54]	93.0 ± 9.0
	2		75	7.63	1.96/1.89	[3.28; 11.98]
	3		150	0.77	1.85/2.83	[−7.94; 9.48]
	4		250	−0.47	1.77/3.47	[−12.89; 11.95]
	5		350	0.43	2.02/3.48	[−11.94; 12.79]
	6		400	−0.07	1.87/2.25	[−6.00; 5.85]
DICLO			250	Internal standard			90 ± 8

: number of repetitions.