Table 2.
Mean residual concentration (%), color changes, and final pH values of apomorphine HCl sample solutions (which were colorless initially) after 336 hours
Apomorphine HCl in different solutions | Experimental temperature (°C) | Mean residual concentration at 336 hours (%)* | Color of solution at 336 hours | Time (day) when color change was first observed | Period of time where mean residual concentration was within 95%–105% (hours) | pH at 336 hours# |
---|---|---|---|---|---|---|
0.1% AA | 25 | 50.02 | Copper | 2 | 10 | 3.88 |
32 | 50.98 | Copper | 1 | 10 | 3.93 | |
37 | 43.69 | Copper | 1 | 5 | 3.93 | |
0.1% SMB | 25 | 0.53 | Very light yellow | 11 | <5 | 3.84 |
32 | 0.05 | Very light yellow | 5 | <5 | 3.63 | |
37 | 0.06 | Light yellow | 3 | <3 | 3.45 | |
0.1% EDTA | 25 | 99.20 | Light blue | 4 | >336 | 4.02 |
32 | 90.17 | Light blue | 2 | 200 | 3.98 | |
37 | 84.58 | Emerald | 0 | 120 | 3.92 | |
0.1% AA +0.1% SMB | 25 | 99.73 | Colorless | – | >336 | 3.94 |
32 | 98.66 | Colorless | – | >336 | 3.81 | |
37 | 95.86 | Colorless | – | >336 | 3.64 | |
0.1% AA +0.1% EDTA | 25 | 85.26 | Colorless | – | 130 | 3.91 |
32 | 70.12 | Yellow | 4 | 45 | 3.98 | |
37 | 74.51 | Yellow | 4 | 50 | 3.91 | |
0.1% SMB +0.1% EDTA | 25 | 88.37 | Colorless | – | 95 | 4.02 |
32 | 77.53 | Colorless | – | 70 | 3.90 | |
37 | 70.72 | Colorless | – | 50 | 3.91 | |
Water (without antioxidant) | 25 | 94.68 | Light blue | 2 | 310 | 4.08 |
32 | 81.23 | Light blue | 1 | 100 | 3.87 | |
37 | 56.84 | Emerald | 0 | 25 | 3.96 |
Notes: Apomorphine HCl sample solutions for each assay were prepared in duplicate (n=2). The initial concentration of sample solutions was 50 μg/mL.
The acceptable limit of mean residual concentration at the end of period of stability study is between 95% to 105%.
Initial pH was buffered by acetate buffer to pH 4.
Abbreviations: AA, L-ascorbic acid; SMB, sodium metabisulfite.