Liquid Chromatography-Tandem Mass Spectrometry Method for the Determination of Vardenafil and Its Application of Bioequivalence
Table 2
Imprecision and accuracy for the determination of vardenafil in plasma.
LLOQ 0.5 ng/mL
LQC 1.5 ng/mL
MQC 25 ng/mL
HQC 45 ng/mL
ULOQ 60 ng/mL
Intraday (n = 6)
Day 1
Mean
0.46
1.48
25.77
47.36
60.16
SD
0.04
2.78
9.17
7.64
4.99
RSD %
9.48
2.81
8.89
7.25
8.29
Accuracy %
92.0
98.9
103.1
105.3
100.27
Day 2
Mean
0.50
1.50
25.14
46.52
61.73
SD
0.01
1.76
2.34
1.76
1.54
RSD %
2.00
1.76
2.33
1.71
2.57
Accuracy %
100.0
100.0
100.6
103.4
100.3
Day 3
Mean
0.45
1.34
25.59
44.84
60.64
SD
0.03
7.06
1.17
8.65
1.77
RSD %
5.88
7.90
1.14
8.68
3.01
Accuracy %
90.0
89.30
102.4
99.6
100.1
Interday (n = 18)
Mean
0.47
1.44
25.50
46.24
59.65
SD
0.03
5.86
1.31
2.86
1.93
RSD %
0.06
6.10
1.29
2.78
3.22
Accuracy %
94.0
96.1
102.0
102.8
99.41
SD: standard deviation; RSD: relative standard deviation; %: percentage; LLOQ: lower limit of quantification; LQC: low quality control; MQC: medium quality control; HQC: high quality control; ULOQ: upper limit of quantification; ng indicates nanograms; mL indicates milliliters.
