@article{16345c7874094fde8ba22d3d01fa0870,
title = "Study on bioequivalence of beraprost in healthy volunteers by liquid chromatography with tandem mass spectrometry",
abstract = "Beraprost sodium is an oral prostacyclin analog that was first approved in 1992 (Japan) for the treatment of peripheral vascular disorders. It is administered orally as a tablet available in strength 20 μg. In this paper, we described a liquid chromatography tandem mass spectrometry method that was developed for the quantification of beraprost in human plasma with high sensitivity at picogram per milliliter concentration. The method had been validated in terms of selectivity, sensitivity, accuracy and precision, matrix effect, linearity, recovery and carry-over according to the Guideline on Bioanalytical Validation from the European Medicines Agency. The standard calibration curve for beraprost was 9.5–1419 pg/mL. This method has been applied successfully to a bioequivalence study with 60 μg of beraprost (three tablets) in 29 healthy volunteers. The results showed that the two formulations of beraprost are bioequivalent.",
keywords = "LC–MS/MS, antiplatelet, beraprost, bioequivalence, pharmacokinetic",
author = "Budi Prasaja and Yahdiana Harahap and Windy Lusthom and Anna Sofiana and Falah Safira and Monika Sandra and Girinanda Puspanegara",
note = "Funding Information: The present method has been applied in a randomized, three‐way, three‐sequence, reference formulation replicated and crossover bioequivalence study with a one‐week washout period in 29 healthy volunteers following a single oral administration of 60 μg of beraprost sodium (20 μg × 3 tablets). The study protocol was approved by the Ethics Committee of the Faculty of Medicine, University of Indonesia and the National Agency of Drug and Food Control, Republic of Indonesia. All participants signed a written informed consent after they had been informed the details of the study. The study was conducted in accordance with Good Clinical Practices and the European Medicines Agency Guidelines on the Investigation of Bioequivalence. The drugs were administered under fasting conditions and blood samplings were carried out at time 0 (pre‐dose) and at 10, 20, 30, 45 min, 1, 1.25, 1.5, 1.75, 2, 3, 4, 5 and 6 h after drug administration. The AUC values were calculated using trapezoidal rule. The Cmax and time to reach Cmax, tmax, were also obtained from observed data. Publisher Copyright: {\textcopyright} 2018 John Wiley & Sons, Ltd.",
year = "2019",
month = feb,
doi = "10.1002/bmc.4403",
language = "English",
volume = "33",
journal = "Biomedical Chromatography",
issn = "0269-3879",
publisher = "John Wiley and Sons Ltd",
number = "2",
}