Table 4.
Type of sample | Solvent Level | Solvent |
Extraction (%)
|
|||
---|---|---|---|---|---|---|
5 min | 15 min | 30 min | 60 min | |||
Intact dosage form | Level 0 | H2O | 5.0 ± 0.4 | 4.4 ± 0.5 | 14.4 ± 0.4 | 23.8 ± 3.1 |
| ||||||
Level 1 | 5% EtOH | 8.9 ± 0.9 | 7.8 ± 0.2 | 11.8 ± 1.2 | 18.7 ± 0.4 | |
40% EtOH | 2.2 ± 0.4 | 5.5 ± 0.4 | 7.6 ± 1.4 | 12.2 ± 1.9 | ||
0.1 M Acetic Acid | 5.0 ± 1.6 | 9.6 ± 0.9 | 15.1 ± 0.8 | 23.7 ± 1.2 | ||
0.1 M NaHCO3 | 4.0 ± 0.9 | 7.5 ± 0.4 | 13.0 ± 0.4 | 19.0 ± 0.3 | ||
0.9% NaCl | 2.9 ± 0.2 | 6.3 ± 1.1 | 9.9 ± 1.9 | 16.2 ± 1.8 | ||
| ||||||
Level 2 | 70% IPA | 0.8 ± 0.1 | 1.9 ± 0.1 | 3.3 ± 0.5 | 6.0 ± 0.9 | |
100% IPA | 0.1 ± 0.0 | 0.2 ± 0.0 | 0.6 ± 0.1 | 1.0 ± 0.1 | ||
0.1 N HCl | 3.4 ± 0.2 | 7.8 ± 0.9 | 11.1 ± 0.4 | 18.0 ± 1.4 | ||
0.1 N NaOH | 3.5 ± 0.4 | 7.8 ± 0.2 | 12.9 ± 1.8 | 18.9 ± 1.2 | ||
Acetone | 0.6 ± 0.1 | 1.3 ± 0.2 | 2.2 ± 0.3 | 3.5 ± 0.5 | ||
| ||||||
Manipulated dosage form | Level 0 | H2O | 45.1 ± 15.8 | 54.3 ± 6.9 | 68.2 ± 5.6 | 76.5 ± 4.7 |
Level 1 | 5% EtOH | 38.0 ± 2.6 | 52.7 ± 2.3 | 63.2 ± 1.8 | 75.2 ± 2.3 | |
40% EtOH | 27.5 ± 1.4 | 49.5 ± 3.0 | 63.7 ± 2.8 | 73.8 ± 1.6 | ||
0.1 M Acetic Acid | 34.2 ± 3.4 | 55.5 ± 2.8 | 67.1 ± 3.2 | 75.4 ± 3.3 | ||
0.1 M NaHCO3 | 22.5 ± 1.8 | 40.0 ± 1.1 | 57.1 ± 2.1 | 68.7 ± 0.8 | ||
0.9% NaCl | 19.9 ± 1.8 | 41.8 ± 2.6 | 55.1 ± 3.3 | 69.0 ± 2.3 | ||
Level 2 | 70% IPA | 22.7 ± 1.3 | 49.1 ± 10.4 | 63.6 ± 3.5 | 75.6 ± 5.4 | |
100% IPA | 19.1 ± 1.8 | 39.0 ± 2.1 | 58.0 ± 1.3 | 69.9 ± 3.1 | ||
0.1 N HCl | 37.5 ± 4.8 | 44.5 ± 4.4 | 51.4 ± 5.3 | 55.5 ± 4.5 | ||
0.1 N NaOH | 21.5 ± 2.2 | 42.5 ± 3.0 | 64.4 ± 4.9 | 86.3 ± 7.4 | ||
Acetone | 45.1 ± 15.8 | 54.3 ± 6.9 | 68.2 ± 5.6 | 76.5 ± 4.7 |