Table 3 Robustness study
Chromatographic changes | Level | Brivaracetam | Eslicarbazepine acetate | Carbamazepine | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
RT | Area | TF | N | RT | Area | TF | N | RT | Area | TF | N | ||
Mobile phase ratio | 38:62 | 1.98 | 301592 | 0.915 | 5846 | 2.78 | 741964 | 1.057 | 6715 | 6.41 | 4201875 | 1.345 | 14025 |
40:60 | 2.05 | 334200 | 0.926 | 6264 | 2.80 | 750839 | 1.015 | 6806 | 6.45 | 4322257 | 0.99 | 15248 | |
42:58 | 2.16 | 350124 | 0.925 | 6584 | 2.93 | 780485 | 1.037 | 7142 | 6.49 | 4436481 | 1.025 | 16055 | |
Mean ± SD | 328639 ± 24739 | 757763 ± 20172 | 4320204 ± 117316 | 1.02 | |||||||||
RSD (%) | 3.40 | 2.66 | 2.72 | ||||||||||
Flow rate (mL/min) | 0.7 | 2.34 | 300188 | 0.930 | 6845 | 3.21 | 708355 | 1.12 | 7038 | 6.93 | 4158410 | 1.10 | 16655 |
0.8 | 2.05 | 334200 | 0.926 | 6264 | 2.80 | 750839 | 1.015 | 6806 | 6.45 | 4322257 | 0.99 | 15248 | |
0.9 | 1.82 | 305486 | 0.921 | 6081 | 2.03 | 735995 | 1.014 | 6682 | 5.91 | 4025014 | 1.00 | 14081 | |
Mean ± SD | 313291 ± 18300 | 758396 ± 26985 | 4201894 ± 156473 | ||||||||||
RSD (%) | 5.84 | 3.56 | 3.72 | ||||||||||
Column temperature (°C) | 45 °C | 1.87 | 301542 | 0.926 | 6522 | 2.78 | 762844 | 0.99 | 6325 | 6.34 | 4211326 | 0.97 | 16051 |
40 °C | 2.05 | 334200 | 0.926 | 6264 | 2.80 | 750839 | 1.015 | 6806 | 6.45 | 4322257 | 0.99 | 15248 | |
35 °C | 2.23 | 318921 | 0.932 | 6125 | 2.83 | 777202 | 1.01 | 6412 | 6.49 | 4225953 | 0.99 | 14583 | |
Mean ± SD | 318221 ± 16340 | 763628 ± 13199 | 4253179 ± 60629 | ||||||||||
RSD (%) | 2.28 | 1.73 | 1.42 | ||||||||||