Summary of validation parameters of chromatographic method used for determination of simeprevir.
| Parameter | Simeprevir |
|---|---|
| Linearity | |
| Regression equation | Y = 54.75X + 15.28 |
| Range (μg mL−1) | 0.1–20 |
| Correlation coefficient (r) | 0.9997 |
| Slope | 54.75 |
| Intercept | 15.28 |
| LOD (μg mL−1) | 0.10 |
| LOQ (μg mL−1) | 0.34 |
| Precision | |
| Repeatability (intra-day) (% RSD) a | |
| QCL (0.5 μg mL−1) | 1.80% |
| QCM (7 μg mL−1) | 1.03% |
| QCH (15 μg mL−1) | 0.71% |
| Intermediate precision (inter-day) (% RSD) a | |
| QCL (0.5 μg mL−1) | 0.70% |
| QCM (7 μg mL−1) | 0.44% |
| QCH (15 μg mL−1) | 0.57% |
| Accuracy | |
| (Mean ± S.D) b | |
| QCL (0.5 μg mL−1) | 100.80 ± 1.54 |
| QCM (7 μg mL−1) | 99.43 ± 1.34 |
| QCH (15 μg mL−1) | 100.67 ± 0.63 |
a
RSD: relative standard deviation.
b
Expressed mean of three replicates.