Development and validation of high performance liquid chromatography (HPLC) method for the determination of bosantan in pure and formulated forms

Abstract

A reversed-phase high performance liquid chromatographic (RP-HPLC) method for the determination of Bosantan (BOS) in bulk material and pharmaceutical formulations has been developed and validated. The chromatographic separation of BOS was performed on an Inertsil C8 column (5 m particle size, 15 cm length x 4.6 mm i.d) with CLC ODS (4 cm x 4.6 mm, i.d.) as a guard column to protect analytical column, a mobile phase consisting of acetate buffer (pH 5.5) acetonitrile in the ratio of 20:80 (v/v) at a flow rate of 1.0 ml/min at ambient temperature using UV detector at 230 nm. The developed method gave good retention time of 2.225 min. The method was found to be specific to BOS and able to resolve the drug peak from formulation excipients. The calibration curve was noticed to be linear over the concentration range of 5-150 ?g/ml (R2 = 0.9999). The method was validated statistically for its selectivity, linearity, precision, accuracy and robustness. In view of this, the method could be employed as a more convenient and efficient option for the analysis of BOS in drug substance and formulations.