Bioequivalence evaluation of Florfenicol pharmaceutics in pigs using liquid chromatography-tandem mass spectrometry
The bioequivalence of two Florfenicol (FF) products in pigs was evaluated. A 2 × 2 crossover trial with a 14 days wash-out period was performed. The pigs were orally administered in a single dose (2 mg/kg b.w of FF). Serum samples were analyzed using a liquid chromatography-tandem mass spectrometry...
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| Published in | Journal of liquid chromatography & related technologies Vol. 41; no. 8; pp. 445 - 450 |
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| Main Authors | , |
| Format | Journal Article |
| Language | English |
| Published |
Abingdon
Taylor & Francis Ltd
09.05.2018
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| Abstract | The bioequivalence of two Florfenicol (FF) products in pigs was evaluated. A 2 × 2 crossover trial with a 14 days wash-out period was performed. The pigs were orally administered in a single dose (2 mg/kg b.w of FF). Serum samples were analyzed using a liquid chromatography-tandem mass spectrometry method. The limit of quantification was 0.1 ng/mL, and the calibration range was 1.0-100.0 ng/mL. Furthermore, intraday and interday were 5.43-9.09% and 6.23-9.68%, respectively. The areas under the curve (AUC0-48) for the test product B of FF and reference product A were 7289.61 ± 1750.44 and 6545.01 ± 2766.25 h × ng/mL, respectively. The highest concentrations of FF in the serum (Cmax) were 726.05 ± 211.77 and 641.97 ± 117.94 ng/mL. The mean retention times (MRT) was 7.91 ± 1.98 and 7.76 ± 2.89 h while the half-lives (T1/2) were 4.07 ± 1.71 and 4.99 ± 3.30 h. From the analysis of variance results, the p values of Cmax and AUC0-∞ for the 90% confidence interval were 0.492 and 0.320 (p > 0.05), respectively. A comparison between the test product and the reference product showed no significant difference. Both products showed bioequivalence after being administered in pigs. |
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| AbstractList | The bioequivalence of two Florfenicol (FF) products in pigs was evaluated. A 2 × 2 crossover trial with a 14 days wash-out period was performed. The pigs were orally administered in a single dose (2 mg/kg b.w of FF). Serum samples were analyzed using a liquid chromatography-tandem mass spectrometry method. The limit of quantification was 0.1 ng/mL, and the calibration range was 1.0-100.0 ng/mL. Furthermore, intraday and interday were 5.43-9.09% and 6.23-9.68%, respectively. The areas under the curve (AUC0-48) for the test product B of FF and reference product A were 7289.61 ± 1750.44 and 6545.01 ± 2766.25 h × ng/mL, respectively. The highest concentrations of FF in the serum (Cmax) were 726.05 ± 211.77 and 641.97 ± 117.94 ng/mL. The mean retention times (MRT) was 7.91 ± 1.98 and 7.76 ± 2.89 h while the half-lives (T1/2) were 4.07 ± 1.71 and 4.99 ± 3.30 h. From the analysis of variance results, the p values of Cmax and AUC0-∞ for the 90% confidence interval were 0.492 and 0.320 (p > 0.05), respectively. A comparison between the test product and the reference product showed no significant difference. Both products showed bioequivalence after being administered in pigs. |
| Author | Tsai, Chin-En Chang, Kai-Chun |
| Author_xml | – sequence: 1 givenname: Kai-Chun surname: Chang fullname: Chang, Kai-Chun organization: Division of Animal Industry, Agricultural Technology Research Institute, Miaoli, Taiwan, ROC – sequence: 2 givenname: Chin-En surname: Tsai fullname: Tsai, Chin-En organization: Department of Veterinary Medicine, College of Veterinary Medicine, National Pingtung University of Science and Technology, Pingtung, Taiwan, ROC |
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| Cites_doi | 10.1016/j.fct.2010.08.039 10.1016/j.rvsc.2013.05.009 10.1128/aac.47.2.820-823.2003 10.1292/jvms.70.99 10.1016/j.jchromb.2008.09.035 10.1111/j.1365-2885.1995.tb00618.x 10.1111/j.1365-2885.2009.01155.x 10.1111/jvp.12020 10.1136/vr.101155 10.1093/jaoac/92.4.1225 10.1080/00071660802613286 10.1039/c4ay00848k 10.1093/jaoac/92.3.981 10.1111/j.1365-2885.2012.01426.x 10.1093/jaoac/92.1.340 10.1021/jf802138y 10.1111/j.1365-2885.2006.00727.x 10.1111/j.1365-2885.2012.01387.x 10.1016/j.jchromb.2011.06.027 10.1292/jvms.10-0243 10.1093/jac/dkh371 10.1016/j.foodchem.2015.01.044 |
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| Title | Bioequivalence evaluation of Florfenicol pharmaceutics in pigs using liquid chromatography-tandem mass spectrometry |
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