NL | Nebivolol |
VL | Valsartan |
RP | Reverse phase |
HPLC | High-performance liquid chromatography |
BA | Bioavailability |
BE | Bioequivalence |
API | Active pharmaceutical ingredient |
UPLC | Ultra-performance liquid chromatography |
UV | Ultraviolet |
QC | Quality control |
RT | Retention time |
USP | United States Pharmacopeia |
CV | Coefficient of variation |
IS | Internal standard |
SD | Standard deviation |
n | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 |
Mean | 7.9880 | 8.0145 | 1.4953 | 1.4902 | 6386.5000 | 6401.5000 | 1194.5000 | 1188.6667 |
SD | 0.02458 | 0.05858 | 0.02273 | 0.01646 | 22.29574 | 21.37054 | 17.14351 | 14.17980 |
% CV | 0.31 | 0.73 | 1.52 | 1.10 | 0.35 | 0.33 | 1.44 | 1.19 |
% Mean accuracy | 99.85 | 100.18 | 99.69 | 99.34 | 99.79 | 100.02 | 99.54 | 99.06 |
% Mean stability | 100.33 | 99.65 | 100.23 | 99.51 |
RT | 2.597 | 3.189 | 4.374 |
Area | 97,579 | 5671 | 11,302 |
USP plate count | 9792.8 | 9135.0 | 8011.3 |
USP tailing | 1.4 | 1.4 | 1.1 |
USP resolution | 4.6 | 6.9 | |
Area ratio | 0.05686 | 0.3545 | |
SD | 0.0316 | 1.00 | |
% CV | 0.0512 | 1.18 |
n | 18 | 18 | 18 | 18 |
Mean | 7.9592 | 1.4937 | 6400.5556 | 1190.4444 |
SD | 0.07785 | 0.01768 | 44.02035 | 30.91016 |
% CV | 0.98 | 1.18 | 0.69 | 2.60 |
% Mean accuracy | 99.49 | 99.58 | 100.01 | 99.20 |
No. of QC failed | 0 | 0 | 0 | 0 |
n | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 |
Mean | 7.9513 | 4.9662 | 1.4943 | 0.4985 | 6403.1667 | 4017.5000 | 1196.000 | 396.5000 |
SD | 0.05211 | 0.10071 | 0.01707 | 0.01320 | 10.60974 | 107.61924 | 11.6666 | 8.06846 |
% CV | 0.66 | 2.03 | 1.14 | 2.65 | 0.17 | 2.68 | 0.97 | 2.03 |
% Mean accuracy | 99.39 | 99.32 | 99.62 | 99.70 | 100.05 | 100.44 | 100.44 | 99.13 |
0.5 | 570 | 0.006 | 400 | 3415 | 0.0350 |
1 | 1235 | 0.013 | 800 | 6724 | 0.0689 |
1.5 | 1785 | 0.018 | 1200 | 10,160 | 0.1041 |
4 | 4643 | 0.048 | 3200 | 26,678 | 0.2731 |
5 | 5880 | 0.060 | 4000 | 34,216 | 0.3506 |
6 | 6902 | 0.071 | 4800 | 41,162 | 0.4217 |
8 | 9176 | 0.094 | 6400 | 52,728 | 0.5402 |
10 | 11,175 | 0.115 | 8000 | 67,420 | 0.6910 |
Correlation coefficient | 0.998 | 0.9994 | |||
Regression equation | y = 1140× | 8.4073× | |||
Linearity range | 0.5–10 ng/mL | 400–8000 ng/mL |
n | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 |
Mean | 9445 | 9253 | 5965 | 5782 | 1886 | 1857 | 54,658 | 53,310 | 35,376 | 34,761 | 10,665 | 10,507 |
SD | 59.17 | 70.20 | 53.57 | 66.05 | 12.32 | 31.02 | 657.59 | 400.50 | 416.36 | 210.54 | 143.61 | 70.53 |
% CV | 0.62 | 0.75 | 0.89 | 1.14 | 0.65 | 1.67 | 1.20 | 0.75 | 1.17 | 0.88 | 1.34 | 0.67 |
% Mean recovery | 97.96 | 96.93 | 98.46 | 97.54 | 98.26 | 98.52 | ||||||
Overall % mean recovery | 97.784 | 98.112 |
n | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 |
Mean | 7.9238 | 4.9362 | 1.4907 | 0.4977 | 6394.3333 | 3999.0000 | 1194.8333 | 393.5000 |
SD | 0.08962 | 0.08039 | 0.01770 | 0.01799 | 15.83246 | 70.11419 | 11.72035 | 6.05805 |
% CV | 1.13 | 1.63 | 1.19 | 3.61 | 0.25 | 1.75 | 0.98 | 1.54 |
% Mean accuracy | 99.05 | 98.72 | 99.38 | 99.53 | 99.91 | 99.98 | 99.57 | 98.38 |
n | 6 | 6 | 6 | 6 |
Mean | 7.9938 | 1.4927 | 6391.6667 | 1193.5000 |
SD | 0.01950 | 0.02082 | 21.42584 | 20.08731 |
% CV | 0.24 | 1.39 | 0.34 | 1.68 |
% Mean accuracy | 99.92 | 99.51 | 99.87 | 99.46 |
n | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 |
Mean | 7.9930 | 7.8872 | 1.4872 | 1.4898 | 6394.5000 | 6391.1667 | 1193.1667 | 1188.5000 |
SD | 0.02481 | 0.15394 | 0.02729 | 0.01393 | 23.57753 | 18.50856 | 20.48821 | 18.98157 |
% CV | 0.31 | 1.95 | 1.83 | 0.94 | 0.37 | 0.29 | 1.72 | 1.60 |
% Mean accuracy | 99.91 | 98.59 | 99.14 | 99.32 | 99.91 | 99.86 | 99.43 | 99.04 |
% Mean stability | 98.68 | 100.18 | 99.95 | 99.61 |
n | 18 | 18 | 18 | 18 | 18 | 18 | 18 | 18 |
Mean | 7.9577 | 4.9657 | 1.4917 | 0.4981 | 6398.5000 | 3993.7222 | 1194.17 | 396.1667 |
SD | 0.07478 | 0.08347 | 0.01596 | 0.01470 | 11.92254 | 79.93071 | 11.1596 | 7.10634 |
% CV | 0.94 | 1.68 | 1.07 | 2.95 | 0.19 | 2.00 | 0.93 | 1.79 |
% Mean accuracy | 99.47 | 99.31 | 99.44 | 99.61 | 99.98 | 99.84 | 99.44 | 99.04 |