Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR DETERMINATION OF RELATED SUBSTANCES OF BORTEZOMIB IN INJECTION

M.N Brinda*, Dr.V .Krishna Reddy, E. SasiKiran Goud, Kadarla Vinay Kumar

ABSTRACT

A simple, sensitive and accurate gradient reverse phase high performance liquid chromatography method was developed for determination of Bortezomib and its five related impurities in injection. The effective separation was achieved on a Hypersil BDS C18 (250 x 4.6 mm), 5μm using a gradient mode by the Mobile phase A: Acetonitrile, Water and Formic acid in the ratio of 30:70:0.1 (v/v/v) and mobile phase B: Acetonitrile, Water and Formic acid in the ratio of 80:20:0.1 (v/v/v).The flow rate of the mobile phase was 1.0 mL/min and the total elution time was 55 minutes. The retention times of Bortezomib and its impurities(IMP-A,B,C,G,H) are 10.853,7.047,4.807,33.007,14.213 and 19.213. The UV detection wavelength was carried at 270 nm and experiments were conducted at 35°C. The developed method was validated in terms of system suitability, selectivity, linearity, precision, accuracy, limits of detection and quantification for the impurities following the ICH guidelines. Therefore, the proposed method was suitable for the simultaneous determination of Bortezomib and its five related impurities.

Keywords: Bortezomib, Related Impurities, Method Development and RP-HPLC.