Simple Determination of Bosentan in Plasma Samples by Reversed-Phase High-Performance Liquid Chromatography

Zahra  Khalighi; Hori  Ghaneialvar; Armin  Soltani; Ali  Khorshidi; Elahe  Karimi; Ardeshir  Moayeri; Naser  Abbasi; Masoumeh  Tahmasebi; Ali  Aidy

doi:10.18502/ajmb.v16i2.14861

Zahra Khalighi Department of Internal Medicine, School of Medicine, Shahid Mustafa Khomeini Hospital, Ilam University of Medical Sciences, Ilam, Iran
Hori Ghaneialvar Biotechnology and Medicinal Plants Research Center, School of Medicine, Ilam University of Medical Sciences, Ilam, Iran
Armin Soltani Department of Internal Medicine, School of Medicine, Shahid Mustafa Khomeini Hospital, Ilam University of Medical Sciences, Ilam, Iran
Ali Khorshidi Department of Epidemiology and Biostatistics, School of Medicine, Ilam University of Medical Science, Ilam, Iran
Elahe Karimi Biotechnology and Medicinal Plants Research Center, School of Medicine, Ilam University of Medical Sciences, Ilam, Iran
Ardeshir Moayeri Department of Anatomy, School of Medicine, Ilam University of Medical Sciences, Ilam, Iran
Naser Abbasi Biotechnology and Medicinal Plants Research Center, Ilam University of Medical Sciences, Ilam, Iran
Masoumeh Tahmasebi Department of Emergency Medicine, School of Medicine, Ilam University of Medical Sciences, Ilam, Iran
Ali Aidy Department of Medical Biotechnology, School of Advanced Technologies in Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran

DOI: https://doi.org/10.18502/ajmb.v16i2.14861

Keywords: Bioequivalence, Bosentan, High performance liquid chromatography, Losartan

Abstract

Background: In order to measure the plasma levels of Losartan and Bosentan, a sensitive Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) technique was developed.

Methods: To compare bioavailability, the Area Under the Curve (AUC), peak plasma concentration (Cmax), and time to Cmax (Tmax) were employed. The standard curve (150-2400 ng/ml) was linear (R²=0.999), relative errors were between 2.4 to 10.05% and the coefficient of variation (CV%) ranged from 1.52 to 10.88. A single dosage (test and reference) was used for the in vivo investigation, which involved 16 healthy individuals.

Results: The AUC0-48, AUC0-, Cmax, and Tmax of the test and reference had no statistically significant differences. The C_max and 95% confidence intervals of the ratio of C_max of the two formulations were 0.93-0.96 and 97.6-135%, respectively.

Conclusion: Therefore, it was established that generic Bosentan was equivalent to Bosentan from Actelion and that both medications could be regarded as equally effective in clinical settings. The blood level of Bosentan could be measured using this straightforward procedure in all hospital laboratories.