Stability Indicating RP-HPLC Method for Bosentan in Tablet Dosage form

  • R. M. Gaurkhede P.W.College of Pharmacy, Dhamangaon road, Yavatmal, 445001 (M.S.)
  • A. V. Chandewar P.W.College of Pharmacy, Dhamangaon road, Yavatmal, 445001 (M.S.)
Keywords: Validation, ICH, RP-HPLC, Stress degradation study


A simple, precise and reproducible stability indicating HPLC method has been developed and validated for determination Bosentan on an Intersil ODS column (250*4.6*5um) using a mobile phase consisting of Disodium phosphate Buffer and acetonitrile (30:70) at flow 1.0 ml/min. Detection was carried out at 273nm . The method was validated with respect to specificity, accuracy linearity, precession, ruggedness and robustness parameters as per ICH guidelines. Linearity of the method was found to be 0.999; %RSD of precession was below 2.0%, recovery of added drug within 98-102 %, System suitability parameters were within limit for Bosentan. The Degradation study was performed during different stress conditions in stability studies. The results obtained in this research work are indicated that the developed method is simple, accurate and precise, sensitive and applicable for analysis in commercially available formulation sample.


Download data is not yet available.

References 2. 3. 4. 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 5. 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. 6. 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. 7. Narendra A, Deepika D, Annapurna MM. New spectrophotometric method for the determination ofbosentan - An anti-hypertensive agent in pharmaceutical dosage forms. E-J. Chem. 2012; 9(2): 700-704. 8. 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. 9. 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. 10. 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. AmericanJ. Sci. Ind. Res. 2012; 3(2): 69-80. 11. International Conference on Harmonization, "Q2A: Text on Validation of Analytical Procedures," Federal Register,1995.

Original Research Articles