Table 3. Accuracy and Repeatability Results from Analytical Method Validation.
| impurity | replicate | % | added (μg/mL) | found (μg/mL) | % recovery | % RSD |
|---|---|---|---|---|---|---|
| DP1 | 1 | 0.05 | 0.2266 | 0.2094 | 92.42 | 1.13 |
| 2 | 0.15 | 0.6798 | 0.6264 | 92.15 | 0.61 | |
| 3 | 0.18 | 0.8157 | 0.7635 | 93.60 | 1.07 | |
| DP2 | 1 | 0.05 | 0.2389 | 0.2384 | 99.81 | 1.34 |
| 2 | 0.15 | 0.7166 | 0.7185 | 100.27 | 0.50 | |
| 3 | 0.18 | 0.8600 | 0.8697 | 101.14 | 0.95 | |
| DP3 | 1 | 0.05 | 0.2628 | 0.2909 | 110.71 | 2.47 |
| 2 | 0.15 | 0.7883 | 0.8878 | 112.63 | 0.28 | |
| 3 | 0.18 | 0.9459 | 1.0653 | 112.62 | 0.30 | |
| DP4 | 1 | 0.05 | 0.3785 | 0.2966 | 78.37 | 0.88 |
| 2 | 0.15 | 0.9378 | 0.9932 | 105.91 | 0.69 | |
| 3 | 0.18 | 1.1355 | 1.0348 | 91.13 | 1.45 | |
| dFCBG | 1 | 0.05 | 0.2823 | 0.3133 | 110.99 | 1.04 |
| 2 | 0.15 | 0.8468 | 0.9144 | 107.99 | 0.29 | |
| 3 | 0.18 | 1.0161 | 1.0948 | 107.75 | 0.87 | |
| 2CBG | 1 | 0.05 | 0.2758 | 0.2857 | 103.60 | 1.57 |
| 2 | 0.15 | 0.8273 | 0.8824 | 106.67 | 0.56 | |
| 3 | 0.18 | 0.9927 | 1.2140 | 122.30 | 0.61 | |
| 4CBG | 1 | 0.05 | 0.3038 | 0.3392 | 111.67 | 4.31 |
| 2 | 0.15 | 0.9113 | 1.0279 | 112.81 | 1.22 | |
| 3 | 0.18 | 1.0935 | 1.2431 | 113.68 | 1.74 | |
| HICBG | 1 | 0.05 | 0.2598 | 0.2701 | 103.99 | 1.91 |
| 2 | 0.15 | 0.7793 | 0.8263 | 106.03 | 0.56 | |
| 3 | 0.18 | 0.9351 | 0.9978 | 106.70 | 0.93 |