| System suitability |
| Tailing factor (<2.0) |
1.3 |
1.2 |
0.9 |
| Plate count
(>2000) |
50906 |
100154 |
75963 |
| RSD% (n = 6 < 2.0) |
0.3 |
0.4 |
0.8 |
| Specificity |
| Diluent/Mobile phase Interference (Should be absent) |
No interference |
No interference |
No interference |
| Placebo interference (Should be absent) |
No Interference |
No Interference |
No Interference |
| Peak purity (Should be passed) |
Passed |
Passed |
Passed |
| Linearity |
| Range (μg/mL) |
1.2–7.5 |
23.6–141.8 |
375–2250 |
| Slope |
139668 |
197415 |
239230 |
| Intercept |
102.05 |
349.85 |
756.46 |
| Correlation
coefficient >0.999 |
0.9999 |
0.9999 |
0.9994 |
| LOQ (μg/mL) |
0.04 |
0.03 |
0.02 |
| Accuracy (n = 6 avg
Percentage) |
| LOQ level ± SD |
100.5 ± 0.3 |
100.8 ± 0.6 |
100.3 ± 0.9 |
| 80% mean ±
SD |
100.1 ± 0.5 |
99.6 ± 0.2 |
99.1 ± 0.6 |
| 100% mean ± SD |
99.3 ± 1.1 |
99.9 ± 0.9 |
99.5 ± 0.4 |
| 120% mean ± SD |
100.3 ± 1.1 |
99.3 ± 0.1 |
99.6 ± 1.5 |
| Precision (Interday, n = 6 RSD% < 2.0) |
0.5 |
0.4 |
0.6 |
| Intermediate Precision (Intraday, n = 6 RSD% < 2.0) |
0.8 |
0.8 |
0.8 |
| Ruggedness (n = 12 RSD% < 2.0) |
0.6 |
0.6 |
0.7 |
| Solution stability B.T (0 and 24 h % difference <2.0) |
0.3 |
0.5 |
0.8 |
| Solution stability 2–8 °C
(0 and 24 h % difference <2.0) |
0.6 |
0.4 |
1.3 |
| Solution stability B.T (0 and 48 h % difference <2.0) |
1.3 |
0.5 |
1.6 |
| Solution stability 2–8 °C
(0 and 48 h % difference <2.0) |
1.6 |
1.1 |
1.4 |
