Table of Contents
Chromatography Research International
Volume 2012, Article ID 801720, 13 pages
http://dx.doi.org/10.1155/2012/801720
Research Article

Development and Validation of a Stability Indicating LC Method for the Assay and Related Substances Determination of a Proteasome Inhibitor Bortezomib

1Active Pharmaceutical Ingredients, Dr. Reddy's Laboratories Ltd., IPDO, Bachupally, Hyderabad 500072, Andhra Pradesh, India
2Department of Chemistry, Osmania University, Hyderabad 500072, Andhra Pradesh, India
3Matrix Laboratories Limited, Plot 34 A, Anrich Industrial Estate, Bollaram, Medak District, Jinnaram, Mandal 502 32, Andhra Pradesh, India

Received 24 February 2012; Accepted 10 May 2012

Academic Editor: Esther Turiel

Copyright © 2012 Kasa Srinivasulu et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

A novel, simple, sensitive, stability indicating HPLC method was developed and validated for quantification of impurities (process related and degradants) and assay determination of bortezomib. Stability indicating power of the method was established by forced degradation experiments and mass balance study. The chromatographic separation was achieved with Waters SymmetryShield RP18 column using gradient elution using the mobile phase-A consists of a mixture of water-acetonitrile-formic acid (715 : 285 : 1, v/v/v) and the mobile phase-B consists a mixture of methanol-water-formic acid (800 : 200 : 1, v/v/v), respectively. The developed method is validated for parameters like precision, accuracy, linearity, LOD, LOQ, and ruggedness. Central composite experimental design (CCD) was applied to check the robustness of the method. The stability tests were also performed on drug substances as per ICH norms.