Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF BOSENTAN IN BULK AND PHARMACEUTICAL FORMULATION

Dr. M. Sumakanth, Y. Sai Kalyani* and A. Chaitanya

Abstract

A simple, rapid and sensitive RP-HPLC method was developed and validated for estimation of Bosentan in tablet dosage form. Chromatography was carried out by using prepacked luna C18, 5μ(250 × 4.6)mm phenomex column as a stationary phase with mobile phase containing a mixture of Acetate buffer (pH 5) : Acetonitrile in the ratio of 68:32 v/v. The flow rate was 1ml/min. The eluent was monitored at 268nm and the retention time of drug is 3.68mins. Calibration curve was plotted with a range of 2-6 μg/ml for Bosentan and the correlation coefficient was found to be 0.999. The developed method was validated in terms of linearity, precision, accuracy, specificity, limit of quantification and limit of detection. The accuracy range was found to be 98-102%. The % RSD value for all validation parameters was found to be less than 2 for RP-HPLC. The developed method can be used for routine analysis of Bosentan in pharmaceutical dosage form as well as bulk was developed and validated according to ICH guidelines.

Keywords: Bosentan, RP-HPLC, ICH guidelines.