Table 1.
HPLC method verification results for insulin assay.
| Analytical Parameter | Result |
|---|---|
| Linearity Range | |
| - 0.9–10.0 mg/mL | R2 = 0.9998 |
| Specificity | |
| - Interference | No interference from formulation components and related compounds |
| Precision (%) | |
| - Inter-day RSD (n = 3 × 3) | 0.8–1.1 |
| - Intra-day RSD (n = 5) | 0.7–0.9 |
| Recovery (%) | 98.3 ± 0.9 |
| DL (mg/mL) | 0.02 |
| QL (mg/mL) | 0.08 |
| Stability of Solution | |
| - Decrease in assay at ambient condition | 2.5% decrease in assay after 24 h |
| System Suitability | |
| - Resolution between insulin and A-21 desamido insulin | 3.7 |
| - Tailing factor for insulin peak | <1.8 |
| - RSD of replicate injections | <1.6% |
DL and QL: detection and quantitation limits, RSD: relative standard deviation.