Table 3 Recovery and stability of Meclizine under different conditions.
Validation parameters | Freeze–Thaw Stability | Long term stability | Stock solution stability | |||
|---|---|---|---|---|---|---|
Low Conc. (10 ng/ml) | High Conc. (200 ng/ml) | Low Conc. (10 ng/ml) | High Conc. (200 ng/ml) | Low Conc. (10 ng/ml) | High Conc. (200 ng/ml) | |
FT Cycle 3 | FT Cycle 3 | After 6 weeks | After 6 weeks | After 6 weeks | After 6 weeks | |
Mean ± SD | 9.880 ± 0.1378 | 196.888 ± 1.757 | 9.775 ± 0.268 | 195.806 ± 0.967 | 10.008 ± 0.050 | 199.975 ± 1.032 |
Precision (CV) % | 1.395 | 0.893 | 2.739 | 0.494 | 0.501 | 0.516 |
Accuracy (%) | 98.798 | 98.404 | 97.746 | 97.903 | 100.084 | 99.987 |
Gross mean degradation (%) | 1.119 | 0.975 | 1.300 | 1.429 | 0.237 | 0.311 |
Validation parameters | Benchtop stability 24 h | Autosampler stability 65 h | Recovery | |||
|---|---|---|---|---|---|---|
Low Conc. (10 ng/ml) | High Conc. (200 ng/ml) | Low Conc. (10 ng/ml) | High Conc. (200 ng/ml) | Low Conc. (10 ng/ml) | High Conc. (200 ng/ml) | |
Mean ± SD | 10.016 ± 0.294 | 200.109 ± 0.651 | 10.006 ± 0.638 | 199.899 ± 0.519 | Peak ratio of drug and IS | Peak ratio of drug and IS |
Precision (CV) (%) | 0.965 | 0.487 | 0.519 | 0.742 | 0.282 (MP) | 0.674 (MP) |
Accuracy (%) | 100.160 | 100.054 | 100.060 | 99.949 | 0.279 (Plasma) | 0.658 (Plasma) |
Gross mean degradation (%) | 0.018 | 0.571 | 0.028 | 0.781 | 98.227% | 99.822% |
