Table 10. Comparison of the Prednisolone Active Ingredient Impurity Profile with the Certificate of Analysis and the Results Obtained with the Official Ph. Eur. Method.
| method used | impurity F (%) | impurity B (%) | impurity A (%) | unknown (%) | unknown (%) | total impurities (%) |
|---|---|---|---|---|---|---|
| certificate of analysis obtained by the prednisolone producer | <LOQ | 0.05 | 0.33 | 0.06 | <LOQ | 0.44 |
| official Ph. Eur. (Table 1) (Venusil AQ C18; 150 × 4.6 mm, 3 μm) | <LOQ | 0.06 | 0.36 | 0.06 | <LOQ | 0.48 |
| developed gradient method (Table 5) (Gemini C18; 150 × 4.6 mm, 3 μm) | 0.06 | 0.06 | 0.36 | 0.07 | 0.05 | 0.60 |