Analytical Method Development and Validation of Bendamustine in Bulk Using RP-HPLC

Authors: Bhawani S*, Nageshwari HG, Mamatha G, Venu M, Sai Krishna M and Murali Krishna KS

DOI: 10.23880/oajpr-16000158

Volume 2, Issue 2

Abstract

A simple, sensitive, precise, accurate and economical method was developed and validated for the estimation of Bendamustine in bulk or formulation by RP-HPLC method using Inertsil column ODS of dimensions ODS -2, (150 x 4.6) mm, 5 µm. The mobile phase (trifluoroacetic acid and acetonitrile ) was pumped at a flow rate of 1.5ml/min in the ratio of 68:32 and the eluents were monitored at 230 nm. Linearity was obtained in the concentration range of 10%-150% with R2 0.999. LOD and LOQ were found to be 2.9 µg/ml and 8.75 µg/ml. The method was statistically validated according to ICH guidelines. RSD was found to be less than 2% indicating high degree of accuracy and precision of the proposed HPLC method. The percentage recovery was in good agreement with the labeled amount in the pharmaceutical formulations.

Keywords: Treanda; HPLC; Trifluoroacetic acid

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