TABLE 1.
Validation parameters of meldonium’s biological method.
| Parameter | Value |
|---|---|
| Correlation coefficient of calibration curve | r 2 = 0.9960 |
| Range of calibration curve | 500–50,000 ng/mL |
| Accuracy deviation | −15.27%–1.18% |
| Intraseries precision | 1.03%–5.57% |
| Interseries precision | 4.63%–8.06% |
| Normalized matrix effect factor | Coefficient of variation of matrix factor: 4.84% and 4.64% |
| Matrix selectivity (mean interference rate) | 1.71% |
| Stability test at 4°C (relative deviation) | 7 days: 1.19% ∼ 3.45%; 21 days: 2.25% ∼ 2.27% |
| Stability test with freeze–thaw at −20°C | 7 days: 91.6%–95.19%; 21 days: 81.8%–89.01% |
| Stability test at room temperature | 4 h: 94.32%–96.9% |
| Carryover effect | ≤20% of LLOQ value |
| Rate of recovery | 99.07% ∼ 105.28% |