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Study on bioequivalence of beraprost in healthy volunteers by liquid chromatography with tandem mass spectrometry.
- Source :
-
Biomedical chromatography : BMC [Biomed Chromatogr] 2019 Feb; Vol. 33 (2), pp. e4403. Date of Electronic Publication: 2018 Nov 28. - Publication Year :
- 2019
-
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.<br /> (© 2018 John Wiley & Sons, Ltd.)
- Subjects :
- Epoprostenol blood
Epoprostenol chemistry
Epoprostenol pharmacokinetics
Humans
Linear Models
Platelet Aggregation Inhibitors blood
Platelet Aggregation Inhibitors chemistry
Platelet Aggregation Inhibitors pharmacokinetics
Reproducibility of Results
Sensitivity and Specificity
Therapeutic Equivalency
Chromatography, Liquid methods
Epoprostenol analogs & derivatives
Tandem Mass Spectrometry methods
Subjects
Details
- Language :
- English
- ISSN :
- 1099-0801
- Volume :
- 33
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- Biomedical chromatography : BMC
- Publication Type :
- Academic Journal
- Accession number :
- 30276833
- Full Text :
- https://doi.org/10.1002/bmc.4403