Stability indicating RP-HPLC method development and validation for the estimation of Betrixaban (BET) in bulk and its pharmaceutical formulations

Abstract

A simple, rapid, sensitive and most economical RP-HPLC method has been developed and validated for the estimation of Betrixaban in bulk and its tablet dosage form. Separation was performed on a Water’s C18 (250 cmx4.6 mm5μm) column at ambient temperature. The mobile phase consisted of Water and ACN in the ratio of 88:12v/v at a flow rate of 1mL/min. The analyte was determined using a photodiode array detector at a detection wavelength of 272nm. The retention time of Betrixaban was found to be 3.284min. The validation of the proposed method was carried out for specificity, linearity, accuracy, precision, limit of detection, limit of quantitation and robustness. The linear dynamic range was from 70 – 210 µg/mL. The percentage recovery obtained for Betrixaban was100.10%. Limit of detection and quantification were 4.96 and 16.52 µg/mL. The developed method can be used for routine quality control analysis of titled drug in tablet formulation.