Table 1.
Summary of linearity data for goserelin, buserelin, triptorelin, and octreotide over the concentration range of 0.5–20.0 ng/mL.
| Analyte | Regression Analysis | Nominal Concentration (ng/mL) | Measured Concentration (ng/mL) |
Maximum E (%) |
|---|---|---|---|---|
| Goserelin |
y = 1.9602x + 0.0007 (R = 0.998) |
0.50 | 0.46–0.58 | 16.0 |
| 1.00 | 0.96–1.14 | 14.0 | ||
| 2.50 | 2.34–2.72 | 8.8 | ||
| 5.00 | 4.64–5.23 | 7.2 | ||
| 10.00 | 9.37–10.47 | 6.3 | ||
| 20.00 | 17.49–21.04 | 12.5 | ||
| Buserelin |
y = 8.2778x + 0.0006 (R = 0.999) |
0.50 | 0.48–0.53 | 6.00 |
| 1.00 | 0.91–1.03 | 9.00 | ||
| 2.50 | 2.13–2.17 | 14.8 | ||
| 5.00 | 5.11–5.34 | 6.8 | ||
| 10.00 | 10.84–11.22 | 12.20 | ||
| 20.00 | 19.75–20.12 | 1.25 | ||
| Triptorelin |
y = 0.8506x + 0.0014 (R = 0.998) |
0.50 | 0.48–0.53 | 6.00 |
| 1.00 | 0.91–1.03 | 9.00 | ||
| 2.50 | 2.13–2.17 | 14.8 | ||
| 5.00 | 5.11–5.34 | 6.8 | ||
| 10.00 | 10.84–11.22 | 12.20 | ||
| 20.00 | 19.75–20.12 | 1.25 | ||
| Octreotide |
y = 1.6853x + 0.0003 (R = 0.998) |
0.50 | 0.49–0.53 | 6.0 |
| 1.00 | 1.00–1.12 | 12.0 | ||
| 2.50 | 2.46–2.70 | 8.00 | ||
| 5.00 | 4.89–5.14 | 2.80 | ||
| 10.00 | 10.17–10.39 | 3.90 | ||
| 20.00 | 17.82–19.16 | 10.90 |
The calculated values of relative standard deviation (RSD, %) and relative error (E, %) meet the guideline acceptance criteria (less than 20% for LLOQ level and less than 15% for other concentration levels).