Table 3 Validation data for the new stability-illustrating RP-HPLC method for CLR and MOX include linear range, robustness, detection and quantification limits, precision, accuracy, specificity, ruggedness, and robustness
Items for validation | Quantified values | Approved standards consistent with the ICH protocol [38] | |
|---|---|---|---|
CLR | MOX | ||
Linearity and range | 400.0 to 1200.0 µg mL−1 r = 0.99988 | 40.0 to 120.0 µg mL−1 r = 0.99984 | r ≥ 0.99 |
Precision (Calculated using 6 replicates) | 0.15 | 0.37 | RSD ≤ 2% |
Accuracy (recovery ± SD) | 99.82% ±0.440 | 99.58% ±1.379 | 100 ± 2% |
Specificity/ Selectivity | Finely resolved peak for CLR from the other peaks for degradation products | Finely resolved peak for MOX from the other peaks for degradation products | Interference was not detected |
LOD | 18.67 µg mL−1 | 2.17 µg mL−1 | Applying the equation: 3.3 x σ / S (σ = the standard deviation of the response, S = the slope of the calibration curve) |
LOQ | 56.58 µg mL−1 | 6.58 µg mL−1 | Applying the equation: 10 x σ / S |
Ruggedness (RSD of peak areas for 3 replicates) | 1.38 (various days) 0.26 (various analysts) | 1.64 (various days) 0.66 (various analysts) | For every modification, Pooled RSD should be ≤ 2% |
Robustness (Slightly manipulates components of the mobile phase) | 1.68 | 1.31 | For every modification, Pooled RSD should be ≤ 2% |