Table 9 Robustness results for dolutegravir
S. No. | Parameter | As such method | Used | %RSD for peak area (n = 6) | Average retention time | Plate count | Tailing factor | Resolution |
|---|---|---|---|---|---|---|---|---|
1 | Flow rate (± 0.1 mL/min) | 1.0 mL/min | 0.9 mL/min | 0.8 | 6.687 | 50185 | 1.12 | 23.47 |
1.0 mL/min | 0.9 | 6.367 | 55945 | 1.14 | 22.51 | |||
1.1 mL/min | 1.2 | 6.354 | 53434 | 1.06 | 21.34 | |||
2 | Column temperature (± 5 °C) | 30 °C | 25 °C | 0.5 | 6.321 | 52290 | 1.11 | 22.49 |
30 °C | 0.9 | 6.367 | 55945 | 1.16 | 22.51 | |||
35 °C | 1.5 | 6.353 | 53457 | 1.07 | 22.37 | |||
3 | Mobile phase composition | Buffer:ACN:Methanol, 55:20:30% v/v | 55:25:25 | 0.7 | 6.322 | 52235 | 1.08 | 22.48 |
55:20:30 | 0.9 | 6.367 | 55985 | 1.13 | 22.51 | |||
55:15:35 | 1.2 | 6.364 | 51769 | 1.04 | 22.58 |