RP-HPLC Method Development and Validation for Estimation of Nilotinib in Bulk and Formulation

Abstract

Nilotinib is an anticancer agent used in the treatment of chronic myelogenous leukemia.A simple, precise, accurate, stable, and economical High-Performance Liquid Chromatography (HPLC) method for the determination of Nilotinib in the capsule dosage form was developed. The chromatographic separation was achieved on Thermo Scientific C18 column (250mm x 4.6mm i.d.5µ). The mobile phase selected was 0.1% trifluoroacetic buffer: acetonitrile in the ratio of 65:35 v/v. The flow rate was 1.0ml/min with 40°C column temperature and 20µl injection volume. The detection was carried out at 260nm. Retention time was observed at 5.888min. The method was linear over the range of 5 to 50 µg/ml with a linear regression coefficient (r²) of 0.999. The HPLC method was validated as per ICH guidelines. This developed method is better for robustness specificity, rapidity, reproducibility, and superior system suitability parameter. Hence the method can be used for the routine analysis of nilotinib in bulk and formulation.