Validation of Simultaneous Quantitative Method of HIV Protease Inhibitors Atazanavir, Darunavir and Ritonavir in Human Plasma by UPLC-MS/MS
Table 6
Stability of atazanavir, darunavir, and ritonavir in human plasma under different conditions.
Storage conditions
Atazanavir
Darunavir
Ritonavir
Mean of six stability samples (ng/mL) SD
% change
Mean of six stability samples (ng/mL) SD
% change
Mean of six stability samples (ng/mL) SD
% change
Bench top stability at ambient temperature; 14 h
LQC
15.23 ± 0.20
1.33
15.41 ± 0.44
2.73
2.954 ± 0.189
−1.53
HQC
4885 ± 155
1.78
4215 ± 215
5.38
417.1 ± 24.65
4.28
Wet extract stability; 24 h, 5°C
LQC
15.42 ± 0.32
2.67
15.24 ± 0.94
1.60
3.068 ± 0.135
2.27
HQC
4893 ± 267
1.94
3975 ± 176
−0.63
418.2 ± 16.75
4.55
Freeze and thaw stability in plasma; 6 cycles, −20°C
LQC
14.74 ± 0.28
−2.11
15.71 ± 0.76
4.73
2.865 ± 0.143
−4.50
HQC
4717 ± 149
−1.73
4058 ± 138
1.45
415.6 ± 21.67
−3.65
Freeze and thaw stability in plasma; 6 cycles, −70°C
LQC
14.96 ± 0.51
−0.67
14.85 ± 0.82
−1.00
2.981 ± 0.176
−0.63
HQC
4687 ± 178
−2.35
4156 ± 202
3.90
378.6 ± 14.39
3.90
Long-term stability in plasma; 60 days, −20°C
LQC
15.31 ± 0.43
2.02
15.28 ± 0.79
1.87
3.073 ± 0.159
2.43
HQC
4924 ± 231
2.58
4187 ± 237
4.68
378.6 ± 17.83
−5.35
Long-term stability in plasma; 60 days, −70°C
LQC
15.53 ± 0.27
3.34
14.98 ± 0.56
−0.13
3.043 ± 0.213
1.43
HQC
5032 ± 97
4.83
3947 ± 191
−1.33
374.9 ± 13.74
−6.28
LQC: low quality control; HQC: high quality control. SD: standard deviation; n: number of replicates at each level. % change = ((mean stability samples – mean comparison samples)/mean comparison samples) × 100.
