New validated RP-HPLC method for the determination of bosentan in bulk and dosage form

Abstract

A New Isocratic RP-HPLC method has been developed and validated for the estimation of Bosentan in bulk and in its pharmaceutical dosage form. Separation was achieved on Agilent LC 1200 HPLC (250mmx4.6mmI.D,5μ) and Methanol: Water(80:20v/v)with 0.2% TEA (pH was adjusted to 3 by Ortho phosphoric acid) as mobile phase at a flow rate 1 mL/min and the column temperature was ambient. UV detection was performed at 268 nm. This method is simple rapid and selective. The described method of bosentan was linear over a range of 20–120μg/mL with retention time 5.3min. The method precision for the determination of assay below 2% RSD. The percentage recoveries of active pharmaceutical ingredient from dosage forms ranged from 98–102%. LOD and LOQ were found to be 0.55, 1.71 μg/mL. The method is useful in quality control of bulk and pharmaceutical formulations. This method was also validated for different parameters like accuracy, precision, linearity, Robustness, limit of detection and limit of quantitation as per ICH guideline.