• THE ESTIMATION OF BORTEZOMIB IN POWDER FOR INJECTION DOSAGE FORMS BY RP-HPLC

Abstract

A simple, precise, rapid and accurate reverse phase HPLC method was developed for the estimation of Bortezomib in  powder for injection dosage form. An Inertsil ODS-3V analytical column (250 x 4.6 mm, 5 μm partical size) with mobile phase consisting of mixture of buffer 0.1% ortho-phosphoric acid in water  and pH adjusted to 6.0 with Triethylamine and acetonitrile in the gradient program was used. The flow rate was 1.0 mL/min and the effluents were monitored at 270 nm. The retention time was 9.7 min. The detector response was linear in the concentration of 2-12 mcg/mL. The respective linear regression equation being  y=1389.7x-1384.1.  The limit of detection and limit of quantification was 0.005mcg/mL and 0.015mcg/mL respectively. The percentage assay of Bortezomib was 99.4 %. The method was validated by determining its accuracy, precision and linearity.