Table I.
System Suitability of 1 μg/mL of Both ETA and PZA (n = 6)
| Parameters | Specificationsa | Day 1 | Day 2 | Day 3 |
|---|---|---|---|---|
| ETA system suitability standard, 1 μg/mL | ||||
| Capacity factor (k′) | >2.0 | 3.22 | 3.21 | 3.21 |
| Capacity factor (RSD) | ≤2.0 | 0.067 | 0.067 | 0.053 |
| Area (% RSD) | ≤2.0 | 1.25 | 1.27 | 1.54 |
| Plates (column) | >3,000 | 35,236 | 34,456 | 35,962 |
| USP tailing | (0.5–2.0) | 1.11 | 1.11 | 1.11 |
| Pyrazinamide system suitability, 1 μg/mL | ||||
| Capacity factor (k′) | >2.0 | 2.46 | 2.42 | 2.43 |
| Capacity factor (RSD) | ≤2.0 | 0.093 | 0.14 | 0.094 |
| Area (% RSD) | ≤2.0 | 0.69 | 1.03 | 1.45 |
| Plates (column) | >3,000 | 12,982 | 13,037 | 16,995 |
| USP tailing | (0.5–2.0) | 0.87 | 0.90 | 1.02 |
Standard deviations of the listed values did not exceed 2%
ETA ethionamide, RSD relative standard deviation, USP United States Pharmacopeia
aAcceptance criteria per the USP 35/NF 30 specifications