AJAC  Vol.3 No.11 , November 2012
Simple Estimation of Bosentan in Tablet Formulation by RP-HPLC
Abstract: A simple, precise, and accurate method is developed and validated for the analysis of Bosentan tablet formulation. The method has shown adequate separation of the ingredients from Tablets. Separation was achieved on a C18 column using a mobile phase consisting of acetonitrile: 10 Mm ammonium acetate (pH 4.5) buffer (70:30, v/v) at a flow rate of 1.0 ml/min and UV detection at 265 nm. This new method is validated as per the ICH, which includes accuracy, precision, selectivity, linearity and range, robustness and ruggedness. The current method demonstrates good linearity over the range of 5 - 70 ng/ml of bosentan with r2 of 0.999. The average recovery of the method is 98.6%. The degree of reproducibility of the results obtained as an outcome of small deliberate variations in the method parameters and by changing analytical operator has proven that this method is robust and rugged.
Cite this paper: S. Muralidharan and J. Kumar, "Simple Estimation of Bosentan in Tablet Formulation by RP-HPLC," American Journal of Analytical Chemistry, Vol. 3 No. 11, 2012, pp. 715-718. doi: 10.4236/ajac.2012.311095.




[4]   B. Lausecker, B. Hess, G. Fischer, M. Mueller and G. Hopfgartner, “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,” Journal of Chromatography B: Biomedical Sciences and Applications, Vol. 749, No. 1, 2000, pp. 67- 83. doi:10.1016/S0378-4347(00)00386-8

[5]   A. S. Jadhav, B. S. Landge, S. L. Jadhav, N. C. Niphade, S. R. Bembalkar and V. T. Mathad, “Stability-Indicating Gradient RP-LC Method for the Determination of Process and Degradation Impurities in Bosentan Monohydrate: An Endothelin Receptor Antagonist,” Chromatography Research International, Vol. 2011, 2011.

[6]   M. M. Annapurna, S. P. S. Bisht, B. V. V. R. Kumar, V. R. Kumar and A. Narendra, “Spectrophotometric Determination of Bosentan and Its Application in Pharmaceutical Analysis,” International Journal of Comprehensive Pharmacy, Vol. 2, No. 2, 2011.

[7]   M. A. Gatzoulis, M. Beghetti, N. Galiè, J. Granton, R. M. F. Berger, A. Lauer, E. Chiossi and M. Landzberg, “Longer-Term Bosentan Therapy Improves Functional Capacity in Eisenmenger Syndrome: Results of the BREATHE-5 Open-Label Extension Study,” International Journal of Cardiology, Vol. 27, No. 1, 2008, pp. 27-32.

[8]   J. M. Parekh, D. K. Shah, M. Sanyal, M. Yadav and P. S. Shrivastav, “Development of an SPE-LC-MS/MS Method for Simultaneous Quantification of Bosentan and Its Active Metabolite Hydroxybosentan in Human Plasma to Support a Bio-equivalence Study,” Journal of Pharmaceutical and Biomedical Analysis, Vol. 70, 2012, pp. 462-470.

[9]   G. Bansal, R. Singh, B. Saini and Y. Bansal, “ESI-MS(n) and LC-ESI-MS Studies to Characterize Forced Degradation Products of Bosentan and a Validated Stability-Indicating LC-UV Method,” Journal of Pharmaceutical and Biomedical Analysis, In Press.

[10]   Center for Drug Evaluation and Research (CDER), “Q2B Validation of Analytical Procedures: Methodology,” Center for Drug Evaluation and Research.