Table 2.
Validation of analytical method for the assays of cetirizine enantiomers and parabens in pharmaceutical formulations.
| Tablets | Oral Drops or Oral Solution | |||||
|---|---|---|---|---|---|---|
| Parameter | (S)-Cetirizine | (R)-Cetirizine | (S)-Cetirizine | (R)-Cetirizine | Paraben M | Paraben P |
| Linearity range, µg·mL−1 | 0.25–25 | 0.25–25 | 0.25–25 | 0.25–25 | 0.45–54 | 0.05–6 |
| LOD, µg·mL−1 (a) | 0.1 | 0.1 | 0.1 | 0.1 | 0.02 | 0.02 |
| LOQ, µg·mL−1 (b) | 0.25 | 0.25 | 0.25 | 0.25 | 0.05 | 0.05 |
| Slope (±SD) | 0.207 (±0.002) | 0.207 (±0.002) | 0.204 (±0.003) | 0.205 (±0.003) | 0.190 (±0.002) | 0.166 (±0.002) |
| Intercept (±SD) | 0.031 (±0.023) | 0.032 (±0.025) | 0.024 (±0.036) | 0.023 (±0.034) | 0.006 (±0.047) | 0.0008 (±0.005) |
| Correlation coefficient, R (R2) | 0.9996 (0.9992) | 0.9996 (0.9991) | 0.9990 (0.9981) | 0.9991 (0.9983) | 0.9997 (0.9993) | 0.9995 (0.9991) |
| Standard error of the regression (sy/x) | 0.05 | 0.05 | 0.08 | 0.07 | 0.10 | 0.01 |
| Number of data points (n) | 11 | 11 | 11 | 11 | 10 | 10 |
(a) LOD—limit of detection; (b) LOQ—limit of quantitation.