Determination of Genotoxic Impurities in Nilotinib using LC-MS Method

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 a...

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Bibliographic Details
Published inResearch journal of pharmacy and technology Vol. 17; no. 3; pp. 1003 - 1007
Main Authors K, Anil Kumar, R., Sudha, Bavireddy, Mohan, V D N Kumar, Abbaraju, Kothakummari, Smita
Format Journal Article
LanguageEnglish
Published Raipur A&V Publications 31.03.2024
Subjects
Acids
Chromatography
Drugs
Kinases
Pharmaceuticals
Retention
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Summary: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.
ISSN:0974-3618
0974-360X
0974-306X
DOI:10.52711/0974-360X.2024.00155