Abstract

STABILITY-INDICATING SPECTROPHOTOMETRIC METHOD OF BOSENTAN IN BULK AND PHARMACEUTICAL DOSAGE FORM

Jagtap Nikhil S.*, Vanjari Suvarna S. and Bhosale Swati D.

ABSTRACT

To develop simple, accurate, precise and cost effective UV-VIS Spectrophotometric method for the estimation of Bosentan in bulk and pharmaceutical dosage form. Bosentan is used to treat pulmonary hypertension. The solvent used was Methanol and the λmax or the absorption maxima of the drug was found to be 270nm. Bosentan was subjected to stress degradation under different conditions recommended by ICH. The sample so generated was used for degradation studies using the developed method. A linear response was observed in the range of 5-25μg/ml with a regression coefficient of 0.998. The method was then validated for different parameters as per the ICH (International Conference on Harmonization) guidelines. The stress degradation studies showed that Bosentan undergoes degradation in acidic, oxidative and alkaline conditions whereas it is relatively stable when exposed to thermal, neutral and photolytic degradation. This method can be used for the determination of Bosentan in quality control of formulation without interference of the excipients.

Keywords: Bosentan, Degradation, Stability- Indicating, UV-Vis Spectrophotometry, Validation.