A Concise Review on Analytical Methods for Determination of Nilotinib

Abstract: Nilotinib hydrochloride is a tyrosine kinase inhibitor licensed to treat chronic myelogenous leukemia in patients with the Philadelphia Chromosome (Ph+). Researchers at Novartis Pharmaceuticals discovered novel inhibitors that are effective against imatinib-resistant BCR-ABL mutations. As a consequence, Nilotinib was discovered. Several analytical approaches were employed to address the quantitative as well as qualitative assessment of Nilotinib from diverse biological and pharmaceutical matrices during the development of Nilotinib. The literature search was conducted by evaluating publications reporting on nilotinib analytical methodologies from 2006 to 2022. This review briefly summarizes the drug profile, viz. stereochemistry, mechanism of action, resistance, pharmacokinetics, pharmacodynamics, side effects, and several analytical techniques used to assess Nilotinib in dosage form, bulk, and biological fluids. The determination of Nilotinib using analytical methods is important for therapeutic drug monitoring, optimizing dosage, ensuring safety and efficacy, and conducting comparative studies. A variety of techniques are gathered and examined, including spectroscopy, electrophoresis, voltammetry, Raman spectroscopy, differential scanning calorimetry, X-ray diffraction, chromatography, and hybrid techniques. They are also useful for studying the pharmacokinetics of the drug. These methods play a crucial role in the effective and personalized treatment of patients with chronic myeloid leukemia and other conditions where Nilotinib is used.