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Abstract

METHOD DEVELOPMENT AND VALIDATION OF NEW RP-HPLC METHOD FOR THE ESTIMATION OF BOSENTAN IN PHARMACEUTICAL DOSAGE FORM

M. Yugandhar*, M. Prasanthi Evangelin and Manohar Babu S.

ABSTRACT

Present study aims to develop rapid, greater sensitivity and faster elution by RP-HPLC method for the estimation of Bosentan. The developed method will be validated in terms of accuracy, precision, linearity, robustness and ruggedness, and results will be validated statistically according to ICH guidelines. The scope of developing and validating analytical methods is to ensure suitable methods for a particular analyte of more specific, accurate, precise and robust. The main objective for this is to improve the conditions and parameters, which should be followed in the development and validation. The existing physicochemical methods are inadequate to meet the requirements, hence it is proposed to improve the existing methods and to develop new methods for the assay of Bosentan.in pharmaceutical dosage forms adapting different available analytical techniques lik HPLC.

Keywords: Bosentan, RP-HPLC, Method Development, Chromatographic Conditions, ICH guidelines.


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