The design of this study followed the recommendations laid down in the "Protocol for research on the stability of drugs in aqueous solutions" by the Dutch Society of Hospital Pharmacists (19). Tropical conditions were simulated (Table II). Taking into account the known vulnerability of ergometrine and methylergometrine to exposure to light, all tablets were tested for light specific degradation (18).
Table II: Definitions of simulated tropical conditions
Test |
Storage condition |
Notation of conditions in text and figures |
| |
|
Temperature |
Relative humidity |
|
I |
dark (D) |
6-10°C |
ambient: 83-85% |
D6/83 |
II |
dark (D) |
20°C |
75% |
D20/75 |
III |
dark (D) |
30°C |
45% |
D30/45 |
IV |
dark (D) |
30°C |
75% |
D30/75 |
V |
dark (D) |
40°C |
ambient: 12-28% |
D40/25 |
VI |
dark (D) |
40°C |
75% |
D40/75 |
VII |
light (L) |
20-25°C; room temperature |
ambient: 20-35% |
L20/30 |