| Sensitivity / LLOQ (μg/ml) |
0.260 |
| Linear range (μg/ml) |
0.173-50 |
| Coefficient R2 |
0.998 |
| Back calculated concentration precision (6.25-0.173 μg/ml) |
1.488 |
| Back calculated concentration Accuracy (6.25-0.173 μg/ml) |
89.121 |
| Intra-assay precision for QC samples, RSD (%) |
QC Samples Conc. (μg/ml) |
After 4 hr. |
After 7 hr. |
After 9 hr. |
Mean of Three periods |
| 25 |
3.53 |
0.24 |
0.64 |
1.47 |
| 6.25 |
1.72 |
3.23 |
0.09 |
1.68 |
| 3.125 |
2.31 |
0.11 |
2.43 |
1.62 |
| 0.781 |
1.36 |
1.02 |
3.35 |
1.91 |
| Intra-assay accuracy for QC samples (%) |
25 |
97.12 |
96.76 |
97.23 |
97.04 |
| 6.25 |
94.23 |
94.54 |
94.03 |
94.27 |
| 3.125 |
86.03 |
87.78 |
86.03 |
86.61 |
| 0.781 |
86.76 |
87.23 |
88.02 |
87.34 |
| Inter-assay precision for QC samples, RSD (%) |
|
Day 1 |
Day 2 |
Day 3 |
Mean of Three days |
| 25 |
1.55 |
2.38 |
1.93 |
1.95 |
| 6.25 |
1.51 |
2.76 |
3.45 |
2.57 |
| 3.125 |
2.46 |
5.08 |
1.90 |
3.15 |
| 0.781 |
2.88 |
8.49 |
3.88 |
5.08 |
| Inter-assay accuracy for QC samples (%) |
|
Day 1 |
Day 2 |
Day 3 |
Mean of Three days |
| 25 |
98.49 |
98.18 |
98.79 |
98.49 |
| 6.25 |
95.41 |
95.68 |
95.58 |
95.56 |
| 3.125 |
88.51 |
88.61 |
87.50 |
88.21 |
| 0.781 |
88.70 |
89.42 |
88.62 |
88.91 |
| Recovery |
|
Absolute n=5 |
Relative n=5 |
| 25 |
80.85 |
100.16 |
| 6.25 |
79.90 |
91.01 |
| 0.781 |
79.05 |
88.78 |
| Stability of Cefuroxime |
|
Accuracy =5 |
Precision n=5 |
| at room temperature (4 hr.) n= 5 |
25 |
98.42 |
1.36 |
| 0.781 |
88.78 |
2.00 |
| Mean of 3Freeze-thaw cycles n=5 |
25 |
93.05 |
3.26 |
| 0.781 |
87.09 |
1.34 |
| Long Term Stability at -20°C |
|
After 2 weeks n=5 |
After 3 weeks n=5 |
| |
Accuracy |
Precision |
Accuracy |
Precision |
| 25 |
95.70 |
1.54 |
88.95 |
0.80 |
| 0.781 |
87.40 |
1.81 |
86.04 |
1.31 |
