Table 8.
Stability data of Salbutamol Sulphate, Cetirizine Hydrochloride FDT at room temperature and at ambient humidity.
| Evaluation parameters | Time interval | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Data of three primary batches on | |||||||||
| 0 day | 15th day | 30th day | |||||||
| B-1 | B-2 | B-3 | B-1 | B-2 | B-3 | B-1 | B-2 | B-3 | |
| Hardness* (Kg/cm2) ± S.D | 1.5 ± 0.29 | 1.8 ± 0.29 | 1.5 ± 0.29 | 1.5 ± 0.00 | 1.5 ± 0.00 | 1.7 ± 0.29 | 1.5 ± 0.00 | 1.5 ± 0.29 | 1.5 ± 0.29 |
| Friability (%) | 1 | 0.6 | 1 | 0.2 | 0.3 | 0.2 | 0.1 | 0.1 | 0.1 |
| Drug content uniformity* (mg) ± S.D | SAL-100.8 ± 3.36, CET-104.7 ± 1.97 |
SAL-95.6 ± 2.34, CET-95.4 ± 2.86 |
SAL-93.8 ± 1.24, CET-97.7 ± 3.97 |
SAL-99.5 ± 2.14, CET-103 ± 1.76 |
SAL-94.5 ± 2.67, CET-98.6 ± 2.07 |
SAL-94.8 ± 1.23, CET-93.4 ± 1.77 |
SAL-98.3 ± 1.98, CET-97.8 ± 2.97 |
SAL-95.4 ± 1.65, CET-97.7 ± 2.75 |
SAL-95.7 ± 3.63, CET-94.2 ± 2.43 |
| Disintegration time** (sec) ± S.D | 39 ± 2.28 | 47 ± 1.80 | 42 ± 3.01 | 42 ± 3.97 | 50 ± 4.52 | 47 ± 1.66 | 46 ± 2.83 | 49 ± 2.52 | 48 ± 3.75 |
*Average of three determinations/batches.
**Average of six determinations/batches.