Determination of Genotoxic Impurities in Nilotinib using LC-MS Method

Determination of Genotoxic Impurities in Nilotinib using LC-MS Method Anil Kumar. K Department of Chemistry, Vel’s Institute of Science, Technology and Advanced Studies, Tamil Naidu, India – 600117. Sudha R. Department of Chemistry, Vel’s Institute of Science, Technology and Advanced Studies, Tamil Naidu, India – 600117. Mohan Bavireddy AGM (Q.C), Tagoor Laboratories Pvt. Ltd., JNPC, Parawada (M), Visakhapatnam – 531021. Abbaraju V D N Kumar Department of Environmental Sciences, GITAM Deemed to be University, Visakhapatnam, India – 530045. Smita Kothakummari Department of Chemistry, Vel’s Institute of Science, Technology and Advanced Studies, Tamil Naidu, India – 600117.

A validated HPLC method was developed for the determination of Nilotinib (Nob) in pharmaceutical formulation. Isocratic elution at a flow rate of 1.0ml/min was employed on Zorbax SB C18 5µm × 4.6mm, 150mm, or similar is used for this chromatography analysis and the column temperature is maintained as ambient. Mobile phase was a mixture of 2.00ml of acetic acid in 2000ml of water as mobile phase A and Acetonitrile 100% as mobile phase B was used. Rate of flow is identified at 1.3ml/min. a 50.0µl sample was injected. The run time is 20 minutes to Sample, blank, system suitability, and sensitivity solution. For the diluted standard solution, it is 60 minutes. The retention time was 1.30minutes. The% R.S.D Nob is identified. The mean percentage recovery for Nob is found within the specification limit. Due to this reason this proposed LC-MS method is successfully adopted to routine quality control analysis in formulations.
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