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Abstract

LIQUID CHROMATOGRAPHY MASS SPECTROMETRIC METHOD FOR QUANTIFICATION OF POTENTIAL GENOTOXIC IMPURITY IN BENDAMUSTINE HYDROCHLORIDE

Kotapati Nalini*, Palnati Narmada, Adibhatla Kali Satya Bhujanga Rao, Gopal Vaidyanathan and Sanasi Paul Douglas

ABSTRACT

A new, simple, accurate and sensitive method was developed for the quantification of potential genotoxic impurity at low level (5.4 ppm) in Bendamustine Hydrochloride using Liquid Chromatographic Mass Spectrometry (LC-MS/MS). The chromatographic separation was achieved on Reliant C18, 5μ (150 x 4.6) mm column with gradient programme and elution was monitored by mass spectrometer in Multiple Reaction Monitoring mode using electrospray ionization. The LOD and LOQ values found to be 0.15 ppm and 0.5 ppm for the impurity with respect to the test concentration 0.5mg/ml. The method was linear (r2>0.99), precise (RSD<2%), accurate and well within acceptable ICH limits.

Keywords: Potential genotoxic impurities, Bendamustine Hydrochloride, LC-MS/MS, Multiple Reaction Monitoring (MRM), Threshold of Toxicological Concern (TTC).


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