Table 4 Results of different analytical method validation parameters
Study | Results |
|---|---|
Specificity | The method was found selective and specific for triamcinolone acetonide eye drops (suspension), since there is no any interference from placebo in the retention time of triamcinolone acetonide active pharmaceutical drug |
Linearity | A linear relation was found for this HPLC method. The correlation co-efficient was found to be 1.00 |
Precision | The results were found within the acceptance value of relative standard deviation (% RSD ≤ 1.0%.) |
System precision | % RSD of triamcinolone acetonide peak areas for six replicate injections of standard solutions are 0.395%, which is less than ≤ 1.0% |
Intraday precision | Cumulative intraday precision of triamcinolone acetonide is 101.48% with cumulative RSD 0.22% respectively |
Inter-day precision | Cumulative inter-day precision of triamcinolone acetonide 101.71% with cumulative RSD 0.31% respectively |
Accuracy & Recovery | The amount of triamcinolone acetonide recovered in recovery I for eye drop were 101.68% with RSD 1.17% respectively |
Range | Range was found to cover 70–130% of the sample concentration |
Stability of analytical test solution | The analytical solution is stable for 24 h when stored at room temperature assay value for 100.37% with RSD 0.87% respectively |
LOD (µg/mL) | Triamcinolone acetonide (active drug) LOD: 0.096 (µg/mL) |
LOQ (µg/mL) | Triamcinolone acetonide (active drug) LOQ: 0.31 (µg/mL) |