Table 1 Results of validation parameter
Concentration of MFP (µg mL−1) | Peak area Mean ± SD (n = 6) | Amount found (μg mL−1) (n = 3) | % amount found (μg mL−1) (n = 3) | % RSD |
|---|---|---|---|---|
Linearity studies of mifepristone | ||||
3 | 348,508 ± 579.06 | – | – | 0.17 |
6 | 637,116 ± 7790.85 | – | – | 1.22 |
9 | 950,741 ± 3787.78 | – | – | 0.40 |
12 | 1,246,160 ± 14,321.09 | – | – | 1.15 |
15 | 1,571,188 ± 9559.71 | – | – | 0.61 |
18 | 1,885,411 ± 12,610.39 | – | – | 0.67 |
Precision studies of mifepristone | ||||
Intra-day precision | ||||
6 | – | 6.00 | 99.98 | 0.11 |
9 | – | 9.00 | 100.00 | 0.06 |
12 | – | 11.94 | 99.48 | 0.90 |
Inter-day precision | ||||
6 | – | 6.02 | 100.36 | 0.40 |
9 | – | 9.02 | 100.24 | 0.11 |
12 | – | 11.94 | 99.54 | 0.57 |
Precision studies [repeatability]of mifepristone | ||||
9 | 8.97 | 99.63 | ||
9 | 9.02 | 100.19 | ||
9 | 9.01 | 100.09 | ||
9 | 9.00 | 100.05 | ||
9 | 9.01 | 100.15 | ||
9 | 9.00 | 100.03 | ||
Mean ± SD | 9.00 ± 0.02 | 100.02 ± 0.20 | ||
% RSD | 0.20 | 0.20 | ||
Ruggedness studies | ||||
9 (Analyst I) | 99.82 ± 0.41 | |||
9 Analyst II) | 99.91 ± 0.27 | |||
Parameters | Tailing factor | Theoretical plates | % RSD | |
|---|---|---|---|---|
Robustness studies of mifepristone | ||||
Change in pH of buffer | ||||
2.8 | 1.43 | 4046.3 | 0.60 | |
3.0 (Optimized condition) | 1.13 | 4097.1 | 0.26 | |
3.2 | 1.21 | 4033.5 | 0.17 | |
Change in mobile phase composition | ||||
Acetonitrile/buffer (45:55) | 1.35 | 4076.5 | 0.67 | |
Acetonitrile/buffer (40:60; optimized condition) | 1.13 | 4097.1 | 0.29 | |
Acetonitrile/buffer (35: 65) | 1.15 | 4087.6 | 0.24 | |
Change in flow rate | ||||
0.4 mL | 1.41 | 4010.4 | 0.75 | |
0.6 mL (Optimized condition) | 1.13 | 4097.1 | 0.38 | |
0.8 mL | 1.26 | 4088.9 | 0.56 | |
Change in temperature | ||||
30 °C | 1.39 | 4038.4 | 0.63 | |
32 °C (Optimized condition) | 1.13 | 4097.1 | 0.44 | |
34 °C | 1.18 | 4054.7 | 0.53 | |
Initial amount (μg mL−1) | Excess drug added to the analyte (%) | Total amount found ± SD (μg mL−1) | Recovery (%) (n = 3) | %RSD (n = 3) |
|---|---|---|---|---|
Accuracy studies of mifepristone | ||||
6 | 80 | 10.77 ± 1.09 | 99.45 | 1.09 |
6 | 100 | 12.02 ± 0.02 | 100.28 | 0.29 |
6 | 120 | 13.23 ± 0.10 | 100.35 | 1.35 |