Determination of Bosentan in Pharmaceutical Dosage Forms by High Performance Liquid Chromatography

Petikam lavudu, Avula Prameela Rani, Are Purna Chander, Chandra Bala Sekaran

Abstract


A simple and sensitive high performance liquid chromatographic method is developed for the estimation of bosentan in pharmaceutical dosage forms. Chromatographic separation of the drug was achieved with an Thermo Scientific C18 column (250 mm × 4.6 mm I.D., 5 μm particle size) analytical column using ammonium bicarbonate (pH was adjusted to 5.0 with phosphoric acid) and acetonitrile (70:30 v/v) as mobile phase. The instrumental settings are flow rate of 1.0 ml/min, column temperature at 25±1°C, detector wavelength of 220 nm and the run time was 5 min. The retention time of the drug was 1.986 min. The developed method shows linearity over a range of 5-100 μg/ml of bosentan with correlation coefficient of 0.9991. The relative standard deviation is less than 1.5%. The proposed method was found to be suitable and accurate for quantitative determination of bosentan in pharmaceutical dosage forms.


Keywords


HPLC; Bosentan; Ammonium bicarbonate; Acetonitrile; Dosage forms.

Full Text:

PDF

References


Raja SG, Dreyfus GD. Current status of bosentan for treatment of pulmonary hypertension. Ann. Card. Anaesth. 2008; 11(1): 6-14.

Gabbay E, Fraser J, McNeil K. Review of bosentan in the management of pulmonary arterial hypertension. Vasc. Health. Risk. Manag. 2007; 3(6): 887–900.

Roux S, Breu V, Ertel SI, Clozel M. Endothelin antagonism with bosentan: A review of potential applications. J. Mol. Med.1999; 77(4): 364-376.

Dingemanse J, Van Giersbergen PL. Clinical pharmacology of bosentan: A dual endothelin receptor antagonist. Clin. Pharmacokinet. 2004; 43(15): 1089-1115.

Annapurna MM, Bisht SPS, Kumar BVVR, Kumar VR, Narendra A. Spectrophotometric determination of bosentan and its application in pharmaceutical analysis. Int. J. Comp. Pharma. 2011; 2 (1): 1-2.

Ashok Kumar A, Anil Kumar A, Sankar DG. Development, estimation and validation of bosentan in bulk and in its pharmaceutical formulation by UV-VIS spectroscopic method. Int. J. Pharma. Bio. Sci. 2011; 2(2): 225-230.

Kumar D, Sreenivas SA, Samal HB, Dey S, Priyanka Y. Method development and estimation of bosentan monohydrate in bulk and pharmaceutical dosage forms using UV-Visible spectrophotometer. J. Pharma. Res. 2011; 4(6): 1713-1715.

Narendra A, Deepika D, Annapurna MM. New spectrophotometric method for the determination of bosentan - An anti-hypertensive agent in pharmaceutical dosage forms. E-J. Chem. 2012; 9(2): 700-704.

Khan MA, Sinha S, Todkar M, Parashar V, Swamy K. Development and validation of a stability indicating analytical method for the related substances of bosentan drug substance by HPLC. American J. Sci. Ind. Res. 2012; 3(2): 69-80.

Jadhav SA, Landge SB, Jadhav SL, Niphade NC, Bembalkar SR, Mathad VT. Stability-indicating gradient RP-LC method for the determination of process and degradation impurities in bosentan monohydrate: An endothelin receptor antagonist. Chromatogr. Res. Int. 2011; 2011(ID 929876): 1-5.

Lausecker B, Hopfgartner G. Determination of an endothelin receptor antagonist in human plasma by narrow-bore liquid chromatography and ion spray tandem massspectrometry. J. Chromatogr. A. 1995; 712(1): 75-83.

Lausecker B, Hess B, Fischer G, Mueller M, Hopfgartner G. Simultaneous determination of bosentan and its three major metabolites in various biological matrices and species using narrow bore liquid chromatography with ion spray tandem mass spectrometric detection. J. Chromatogr. B. Biomed. Sci. Appl. 2000; 749(1): 67-83.

Muralidharan S, Kumar JR. Simple estimation of bosentan in tablet formulation by RP-HPLC. American J. Anal. Chem. 2012; 3(11): 715-718.

Reddy TK, Younus Md, Reddy YR, Kumar GA, Sravan S. RP-HPLC method development and validation of bosentan drug present in tablets. Int. J. Pharma. Tech. 2010; 2(3): 577-587.

Rao TN, Patrudu TB, Raghubabu K, Nagachandrudu S, Sreenivasulu D, Reddy EGS. Estimation of bosentan monohydrate in tablet dosage forms by a new RP-HPLC method. Am. J. PharmTech Res. 2012; 2(5): 391-398.

Validation of Analytical Procedures; Methodology, International Conference on Harmonization (ICH), Text and Methodology Q2(R 1), Complementary Guideline on Methodology dated 06 November 1996, incorporated in November 2005, London.


Refbacks

  • There are currently no refbacks.




Copyright (c)

               AR Journals

18K, Street 1st, Gaytri Vihar, Pinto Park, Gwalior, M.P. India

Copyright@arjournals.org (Design) 2009-2021

 

Follow @arjournals on Twitter