aBlood Products Teams, National Institute of Food and Drug Safety Evaluation, Osong, Korea
bBiologics Division, Korea Food and Drug Administration, Osong, Korea
© 2011 Published by Elsevier B.V. on behalf of Korea Centers for Disease Control and Prevention.
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Extraction volume | Recovery (%) | Histamine area | IS area |
---|---|---|---|
2 mL | 111.72–112.92 | 19.12–20.16 | 29.63–30.88 |
5 mL | 108.63–115.92 | 9.69–10.60 | 14.45–14.54 |
Spiked amount (μg) | Final conc. (μg/mL) | HPLC analysis result (μg/mL) | RSD (%) | Recovery (%) |
---|---|---|---|---|
0.05 | 0.025 | 0.0258 ± 0.0008 | 3.27 | 103.2 |
0.10 | 0.050 | 0.0490 ± 0.0019 | 3.85 | 97.9 |
0.15 | 0.075 | 0.0713 ± 0.0024 | 3.34 | 95.0 |
0.20 | 0.100 | 0.0916 ± 0.0017 | 1.89 | 91.6 |
0.30 | 0.150 | 0.1525 ± 0.0014 | 0.94 | 101.7 |
Histamine spiked (μg) | Histamine concentration (μg/mL) | Day | Histamine conc. (μg/mL) | RSD (%) | Recovery (%) |
---|---|---|---|---|---|
0.15 | 0.075 | 1 | 0.0747 ± 0.0004 | 0.51 | 99.59 |
0.15 | 0.075 | 2 | 0.0777 ± 0.0004 | 0.56 | 103.61 |
0.15 | 0.075 | 3 | 0.0784 ± 0.0011 | 1.40 | 104.47 |
HPLC analysis | R2 | Dose response curve parameters | |
---|---|---|---|
Slope | Intercept | ||
Day 1 | 0.9950 | 0.0245 | −0.1880 |
Day 2 | 0.9916 | 0.0243 | −0.1930 |
Day 3 | 0.9928 | 0.0277 | −0.0892 |
Mean ± SD | 0.9931 ± 0.0017 | 0.0255 ± 0.0019 | −0.1567 ± 0.0585 |
Mean ± SD ( RSD = relative standard deviation.
Mean ± SD ( RSD = relative standard deviation.
SD = standard deviation.