Research Article
Validation of Simultaneous Quantitative Method of HIV Protease Inhibitors Atazanavir, Darunavir and Ritonavir in Human Plasma by UPLC-MS/MS
Table 2
Intrabatch and interbatch precision and accuracy for atazanavir, darunavir, and ritonavir.
|
QC level (nominal
concentration) | Intrabatch (n = 6; single batch) | Interbatch (n = 30; 6 from each batch) | Mean concentration
observed (ng/mL) | % CV | % Accuracy | Mean concentration
found for 5
batches (ng/mL) | % CV | % Accuracy |
| | Atazanavir | | LLOQ QC (5.0 ng/mL) | 5.21 | 6.3 | 104.1 | 5.05 | 5.1 | 101.0 | | LQC (15 ng/mL) | 14.5 | 4.5 | 96.8 | 14.9 | 1.5 | 99.4 | | MQC-2 (150 ng/mL) | 142.8 | 2.8 | 95.2 | 153.9 | 4.3 | 102.6 | | MQC-1 (2400 ng/mL) | 2362 | 3.4 | 98.4 | 2482 | 0.8 | 103.4 | | HQC (4800 ng/mL) | 4886 | 3.3 | 101.8 | 4814 | 3.2 | 100.3 |
| | Darunavir | | LLOQ QC (5.0 ng/mL) | 4.89 | 6.9 | 97.8 | 4.97 | 7.3 | 99.5 | | LQC (15 ng/mL) | 14.3 | 4.1 | 95.3 | 14.7 | 3.2 | 98.1 | | MQC-2 (150 ng/mL) | 149.5 | 1.9 | 99.7 | 153.0 | 1.4 | 102.0 | | MQC-1 (2000 ng/mL) | 2088 | 3.0 | 104.4 | 1936 | 3.5 | 96.8 | | HQC (4000 ng/mL) | 3832 | 2.3 | 95.8 | 3808 | 1.4 | 95.2 |
| | Ritonavir | | LLOQ QC (1.0 ng/mL) | 0.95 | 5.8 | 95.0 | 0.93 | 5.8 | 92.7 | | LQC (3.0 ng/mL) | 2.78 | 4.9 | 92.7 | 2.86 | 1.3 | 95.2 | | MQC-2 (30 ng/mL) | 30.7 | 1.9 | 102.2 | 30.9 | 2.9 | 103.2 | | MQC-1 (200 ng/mL) | 182.6 | 3.8 | 91.3 | 189.2 | 4.4 | 94.6 | | HQC (400 ng/mL) | 385.6 | 4.9 | 96.4 | 404.4 | 1.9 | 101.1 |
|
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CV: coefficient of variation; LLOQ: lower limit of quantitation; LQC: low quality control; MQC: medium quality control; HQC: high quality control.
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