Sat, 18 Nov 2017

Simultaneous Quantitation of Two Potential Genotoxic Impurities In Imatinib by Liquid Chromatography Mass Spectrometry

Kotapati Nalini1*, 2, Palnati Narmada1, Adibhatla Kali Satya Bhujanga Rao1, Gopal Vaidyanathan1, Sanasi Paul Douglas2

1. Natco Pharma Limited, Natco Research Centre, B-13, Industrial Estate, Sanathnagar, Hyderabad-500018, Telangana, India.

2. Department of Engineering Chemistry, Andhra University, Vishakhapatnam, Andhra Pradesh, India


ABSTRACT

A new, simple, accurate and sensitive method was developed for the quantification of two potential genotoxic impurities 1-(2-methyl-5-nitro-phenyl)guanidine nitrate and  N-(2-methyl-5-nitro-phenyl)-4-(3-pyridyl)pyrimidin-2-amine at low level (2 ppm) in Imatinib using liquid chromatographic mass spectrometry. The chromatographic separation was achieved on Kromasil 100-3.5-C18 (150 x 2.1) mm column with gradient programme and elution was monitored by mass spectrometer in selective ion monitoring mode using electrospray ionization. The LOD and LOQ values found to be 0.2 ppm and 0.6 ppm for both the impurities with respect to the test concentration 5 mg/ml. The method was linear (r2>0.99), precise (RSD<2%), accurate and well within acceptable ICH limits.

Keywords: Potential genotoxic impurities, Imatinib, LC-MS, Selective Ion Monitoring (SIM), Threshold of Toxicological Concern (TTC)


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