Table 13 Results of forced degradation studies (n = 6)
Degradation condition | Number of degradation products (Rt values) | %Area of degradation product | %Drug degraded |
|---|---|---|---|
Oxidation | 3 (2.24, 2.32, 2.60) | 22.45, 44.10, 9.85 | 76.41 |
Acid | 3 (2.27, 2.68, and 7.06) | 40.69, 3.63, 3.78 | 48.12 |
Base | 6 (2.06, 2.42, 2.68, 2.77,2.99, 4.07) | 2.07, 7.75, 0, 19.45, 23.27, 43.92 | 96.49 |
Neutral | 0 | 0 | 0 |
Photo (sunlight) | 1 | 0.20 | >1 |
Thermal | 2 (2.23, 3.13) | 5.57, 0.74 | 6.32 |