Table 3.
Stability of choline salicylate eye drops formulated using Preparations I and II stored under controlled conditions (40 °C/75% RH) in bottles and minims—results of CS determinations by HPLC and measurement of pH, viscosity, and osmolarity (mean ± SD, n = 3).
| Package | Time, Months | Determined Concentration, % | Percentage of Declared Value, % | pH | Viscosity, mPa·s | Osmolarity, mOsm/L |
|---|---|---|---|---|---|---|
| Preparation I | ||||||
| Bottle | 0 | 2.12 ± 0.09 | 100.0 ± 4.2 | 7.41 ± 0.05 | 9.56 ± 0.06 | 314 ± 2 |
| 1 | 2.09 ± 0.08 | 98.6 ± 3.8 | 7.41 ± 0.03 | Nd | 312 ± 1 | |
| 2 | 2.07 ± 0.05 | 98.5 ± 2.4 | 7.41 ± 0.03 | Nd | 313 ± 1 | |
| 3 | 2.10 ± 0.06 | 96.5 ± 2.8 | 7.40 ± 0.01 | 9.38 ± 0.04 | 311 ± 1 | |
| 4 | 2.00 ± 0.04 | 96.1 ± 1.9 | 7.41 ± 0.07 | Nd | 312 ± 1 | |
| 5 | 2.00 ± 0.08 | 96.5 ± 3.8 | 7.40 ± 0.01 | Nd | 311 ± 2 | |
| 6 | 2.14 ± 0.11 | 98.5 ± 5.2 | 7.41 ± 0.08 | 9.24 ± 0.05 | 312 ± 2 | |
| Minims | 0 | 2.12 ± 0.09 | 100.0 ± 4.2 | 7.41 ± 0.05 | 9.56 ± 0.06 | 314 ± 2 |
| 1 | 2.13 ± 0.04 | 100.5 ± 1.9 | 7.52 ± 0.02 | Nd | 313 ± 2 | |
| 2 | 2.18 ± 0.05 | 102.8 ± 2.4 | 7.63 ± 0.05 | Nd | 313 ± 2 | |
| 3 | 2.34 ± 0.09 | 110.4 ± 4.2 | 7.67 ± 0.03 | 7.45 ± 0.02 | 309 ± 2 | |
| Preparation II | ||||||
| Bottle | 0 | 2.01 ± 0.04 | 100.0 ± 2.0 | 7.80 ± 0.05 | 9.93 ± 0.02 | 298 ± 1 |
| 6 | 2.01 ± 0.04 | 100.0 ± 2.0 | 7.61 ± 0.05 | 6.91 ± 0.06 | 320 ± 1 | |
| Minims | 0 | 2.01 ± 0.04 | 100.0 ± 2.0 | 7.80 ± 0.05 | 9.93 ± 0.01 | 298 ± 1 |
| 3 | 2.04 ± 0.06 | 101.5 ± 3.0 | 7.65 ± 0.03 | Nd | 300 ± 2 | |
| 6 | 2.32 ± 0.01 | 115.4 ± 0.5 | 7.50 ± 0.05 | 6.41 ± 0.05 | 298 ± 1 | |
Note: Nd—no data.