Bioequivalence evaluation of Florfenicol pharmaceutics in pigs using liquid chromatography-tandem mass spectrometry

• Published in: Journal of liquid chromatography & related technologies Vol. 41; no. 8; pp. 445 - 450
• Main Authors: Chang, Kai-Chun, Tsai, Chin-En
• Format: Journal Article
• Language: English
• Published: Abingdon Taylor & Francis Ltd 09.05.2018
• Subjects: Calibration; Chromatography; Confidence intervals; Florfenicol; Liquid chromatography; Mass spectrometry; Mass spectroscopy; Oral administration; Scientific imaging; Spectroscopy; Variance analysis
• ISSN: 1082-6076; 1520-572X
• DOI: 10.1080/10826076.2018.1448869

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.