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. Author manuscript; available in PMC: 2017 Mar 16.
Published in final edited form as: Int J Pharm. 2016 Jan 16;500(0):255–267. doi: 10.1016/j.ijpharm.2016.01.031

Table 4.

Extraction of intact and manipulated sotalol test formulation 1 in 100 mL of water and different solvent at room temperature. (n=3)

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