Development and validation of a stability indicating analytical method for the related substances of Bosentan drug substance by HPLC

  title={Development and validation of a stability indicating analytical method for the related substances of Bosentan drug substance by HPLC},
  author={M. A. Khan and Sukumar Sinha and Mangesh Todkar and Vikas Parashar and K. C. Narayana Swamy and Navi Mumbai},
  journal={American Journal of Scientific and Industrial Research},
An accurate & sensitive stability indicating analytical method has been developed for the control of impurities in Bosentan API. Four impurities (impurity A, B, C & D) were isolated from the API and were characterized by spectroscopic studies. An HPLC equipped with quaternary gradient pumps, variable wavelength UV detector attached with data recorder and integrator software was used. A Zorbax SB-C8 (250 x 4.6mm, 5µ) column at 25°C was used with a flow rate of 1.0 ml/min and the compounds were… 

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