European Journal of Biomedical and Pharmaceutical Sciences

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF BOSENTAN MONOHYDRATE IN BULK AND TABLET DOSAGE FORM

Rutuja Prabhakar Sonare*, Dr. Ashok Pandurang Pingle, Komal Ashok Rajgire, Rina Mohan Sonawane and Snehal Ganpat Tekawade

ABSTRACT

A simple, rapid, economic, sensitive and precise Stability indicating RP-HPLC method has been developed for the determination of Bosentan Monohydrate in bulk and pharmaceutical dosage form. The method is carried out using Grace C18 (4.6ID×250mm; 5μm) column and mobile phase comprised of Methanol: Potassium dihydrogen phosphate buffer in proportion of ratio 90:10v/v and degassed under ultrasonication. The flow rate was 0.9ml/min and detection was carried out at 222nm. The retention time of Bosentan Monohydrate were found to be 4.963min. The method was validated in terms of linearity, precision, accuracy, limit of detection, limit of quantitation, robustness and ruggedness. The method was also applied for the determination of Bosentan Monohydrate in presence of their degradation products formed under variety of stressed conditions. Degradation product produce as a result of stress studies did not interfere with the Bosentan Monohydrate and the assay can thus be considered stability indicating. The proposed method is suitable for the routine quality control analysis for determination of Bosentan Monohydrate in bulk and pharmaceutical dosage form.

Keywords: Bosentan Monohydrate, RP-HPLC, stability indicating, stress studies, validation.