Research Article
Development and Validation of Discriminative Dissolution Method for Metformin Immediate-Release Film-Coated Tablets
Table 3
Validation of the proposed dissolution method for metformin film-coated tablets.
| | Validation parameters | Acceptance criteria | Obtained results |
| | Specificity | No interference of diluent and placebo with metformin HCl | Conforms |
| Accuracy
Recovery level (%) | The average recovery for each level should be between 95.0 and 105.0%, and RSD should be not more than 5.0% | Recovery (%) (average n = 3) | 95% confidence interval | RSD% | | 120% | | 101.01% | ±1.36% | 0.54% | | 100% | | 101.49% | ±7.15% | 2.84% | | 80% | | 101.86% | ±1.34% | 0.53% |
| | Precision | RSD < 2% | | | | | Method precision | | RSD = 1.68% (n = 6) |
| | Precision | F value < 5.05 | Day I (%) | Day II (%) | | Intermediated precision | RSD < 2% | 100.55% | 96.13% | | | | 98.11% | 98.02% | | | | 96.04% | 95.63% | | | | 98.59% | 96.45% | | | | 99.78% | 98.61% | | | | 97.20% | 98.79% | | | | RSD = 1.68% | RSD = 1.40% | | | | F = 1.47 |
| | Linearity (within 25%–150% of the working concentration) | Correlation coefficient (r2) should be ≥0.995 | r2 = 0.99986
y = 0.00473 + 79.22x |
| | Robustness | F < 5.05 | Change | Recovery (%) | F value | | pH value ±2 units | | 6.8 | — | — | | | 6.6 | 99.96% | 1.09 | | | 7.0 | 100.01% | 1.03 | | Speed of dissolution tester ±5 rpm | | 75 rpm | — | — | | | 70 rpm | 99.99% | 1.77 | | | 80 rpm | 96.84% | 2.82 | | Тemperature of dissolution medium ±5°С | | 37.0°С | — | — | | | 36.5°С | 100.73% | 3.03 | | | 37.5°С | 99.81% | 2.58 |
| | Stability of solutions | Recovery should be between 95.0 and 105.0% | Recovery (%) | | Fresh preparation | | — | | 5 hours | | 100.00% | | 24 hours | | 99.50% | | 48 hours | | 98.60% |
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