Table 1 Summary of forced degradation study results
Stress condition | Time | Assay% of PP after degradation | Assay% of IP after degradation | Remarks |
|---|---|---|---|---|
Unstressed sample | – | 99.63 | 100.2 | – |
Acid hydrolysis (1.0N HCl) | 60 min | 91.15 | 98.64 | The significant degradation was observed. |
Base hydrolysis (1.0N NaOH) | 60 min | 96.01 | 93.78 | The slight degradation of analytes was observed. |
Oxidation (10% H2O2) | 60 min | 98.65 | 99.12 | Significant degradation was not observed. |
Thermal (80 ° C) | 8 h | 99.32 | 99.81 | Significant degradation was not observed. |
Photolytic degradation | 24 h | 99.53 | 99.98 | Significant degradation was not observed. |