Abstract

DEVELOPMENT AND VALIDATION OF PROTEASOME INHIBITOR (BORTEZOMIB) BY RP-HPLC METHOD IN BULK DRUG AND PHARMACEUTICAL DOSAGE FORMS

Suresh Kumar Agrawal*, Ashok Sharma and Devendra Singh Rathore

ABSTRACT

A simple, rapid, sensitive and precise high performance liquid chromatographic (HPLC) method has been developed for the estimation of Bortezomib in bulk and formulated dosage form. In this method Hypersil BDS packed with Octadecylsilyl silica gel (100mmx4.6mmx3μm) with mobile phase consisting of acetonitrile: water: formic acid in the ratio of 35:65:0.1 v/v in isocratic mode was used. The detection wavelength is 270 nm and the flow rate is 0.8 ml/min. In the range of 50-300 μg/ml, the linearity Bortezomib shows a correlation coefficient of 0.999. The proposed method was validated by determining sensitivity, accuracy, precision and system suitability parameters. The mobile phase selected for the method is simple, fast, accurate and precise and hence can be applied for routine quality control analysis of Bortezomib in bulk and its formulated dosage form.

Keywords: RP-HPLC, Proteasome inhibitor, Bortezomib, Stability Validation, Assay.