DEVELOPMENT AND VALIDATION OF UV-VISIBLE SPECTROPHOTOMETRIC METHOD FOR ANALYSIS OF BOSENTAN IN SPIKED HUMAN PLASMA
Objective: The aim of the present study is to develop and validate a simple, efficient, economical and accurate UV-visible spectrophotometric method for estimation of bosentan in spiked human plasma.
Methods: The analyte was extracted by Liquid-liquid Extraction (LLE) procedure using acetonitrile and chloroform. Absorbance of the analyte in the extract was measured at 270 nm using ethanol as a diluent. The developed method was validated for linearity, accuracy and robustness.
Results: The proposed method was found to be linear in the range of 6 to 18 mg/ml. The correlation coefficient (r2) was found to be 0.99. The results revealed that the linearity, accuracy and robustness of the developed method were within the acceptable range.
Conclusion: The analytical technique presented here demonstrates shorter and easier sample preparation method, decreased analysis time and reduces the need for complicated or expensive equipment. The sample preparation method used in this study can also be further extended to higherend analytical techniques and other biological samples for quantification of bosentan.
2. LJ Rubin, DB Badesch, RJ Barst. Bosentan therapy for pulmonary arterial hypertension. New England J Med 2002;346:896-903.
3. Kiowski W, Kim J, Oechslin E, Sutsch G, Hunziker P, Muller P, et al. Evidence for endothelin-1-mediated vasoconstriction in severe chronic heart failure. Lancet 1995;346:732-6.
4. Paul LM, Van Giersbergen, Atef Halabi, Jasper Dingemanse. Single-and multiple-dose pharmacokinetics of bosentan and its interaction with ketoconazole. Br J Clin Pharmacol 2002;53:589-95.
5. JM Pearl, SA Wellmann, JL McNamara. Bosentan prevents hypoxia-reoxygenation-induced pulmonary hypertension and improves pulmonary function. Annals Thoracic Surgery 1999;68:1714-21.
6. Parekh JM, Shah DK, Sanyal M, Yadav M, Shrivastav PS. Development of an SPE-LC–MS/MS method for simultaneous quantification of bosentan and its active metabolite hydroxybosentan in human plasma to support a bioequivalence study. J Pharm Biomed Anal 2012;70:462-70.
7. Atila A, Ozturk M, Kadioglu Y, Halici Z, Turkan D, Yayla M, et al. Development and validation of UFLC MS/MS method for determination of bosentan in rat plasma. J Pharm Biomed Anal 2014;97:33-8.
8. Xiang J, Jian LZ, Zhe W, Zhisheng X, Ren-ai X. Simultaneous determination of bosentan and glimepiride in human plasma by ultra-performance liquid chromatography tandem mass spectrometry and its application to a pharmacokinetic study. J Pharm Biomed Anal 2014;95:207-12.
9. Yoshinari Y, Miho T, Hideki H, Keita H, Yasuo O, Yuto Y, et al. Simultaneous micro determination of bosentan, ambrisentan, sildenafil, and tadalafil in plasma using liquid chromatography/ tandem mass spectrometry for pediatric patients with pulmonary arterial hypertension. J Pharm Biomed Anal 2014;89:227-32.
10. Gilant E, Bus Kwasnik K, Domel I, Kaza M, Rudzki PJ. Influence of hydroxybosentan on determination of bosentan in human plasma. Peer J Pre Prints 2015;3:e1539v1.
11. Sanaz Sajedi Amin, Karim Assadpour Zeynali, Vahid Panahi Azar, Abbas Kebriaeezadeh, Maryam Khoubnasabjafari, Khalil Ansarin, et al. Spectroscopic analysis of bosentan in biological samples after a liquid-liquid microextraction. BioImpacts 2015;5:191-7.
12. Zamani Kalajahi M, Fazeli Bakhtiyari R, Amiri M, Golmohammadi A, Afrasiabi A, Khoubnasabjafari M, et al. Dispersive liquid-liquid microextraction based on solidification of floating organic droplet followed by spectrofluorimetry for determination of carvedilol in human plasma. Bioanalysis 2013;5:437-48.
13. D Launay, O Sitbon, JL Pavec. Long-term outcome of systemic sclerosis-associated pulmonary arterial hypertension treated with bosentan as first-line monotherapy followed or not by the addition of prostanoids or sildenafil. Rheumatology 2010; 49:490-500.
14. Channick RN, Simonneau G, Sitbon O, Robbins IM, Frost A, Tapson VF, et al. Effects of the dual endothelin-receptor antagonist bosentan in patients with pulmonary hypertension: a randomised placebo controlled study. Lancet 2001;358:1119-23.
15. Bioanalytical Method Validation-U. S. Food and Drug Administration; 2018. p. 1-37.
16. Beghetti M, Haworth SG, Bonnet D, Barst RJ, Acar P, Fraisse A, et al. Pharmacokinetic and clinical profile of a novel formulation of bosentan in children with pulmonary arterial hypertension: the FUTURE-1 study. Br J Clin Pharmacol 2009;68:948-55.
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