Research Article
Stability-Indicating HPLC Determination of Gemcitabine in Pharmaceutical Formulations
Table 6
Stability data under different stressed conditions.
| | Stress conditions | Percent gemcitabine remained | Retention time of degraded products |
| | Alkaline stress (1 N, NaOH, 60°C, 1 h) | 16.1 ± 0.2% | 3.023 (d-1), 3.202 (d-2), 3.645 (d-3), 4.342 (d-4), 4.944 (d-5), and 5.375 (d-6) | | Acidic stress (1 N HCl, 60°C, 1 h) | 95.0 ± 0.2% | 4.953 (d-5), 6.082 (d-7), and 7.131 (d-8) | | Oxidative stress (5%, 60°C, 1 h) | 97.1 ± 0.1% | 3.772 (d-3) | | Aqueous hydrolytic stress (60°C, 1 h) | 99.2 ± 0.1% | 4.952 (d-5) | | Ultraviolet light (100 W/m2, 1 h) | 100.0% | 0.0 | | Direct sunlight (1 h) | 100.0% | 0.0 | | Aqueous stability (after 21 days) | 99.9 ± 0.1% | 0.0 |
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