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1 2014

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Forced degradation study and validated stability-indicating RP-LC method for determination of nilotinib in bulk and capsules

Fouad M. A., Elkady E. F.

Acta Chromatographica

2014

Vol. 26, no. 4

637--647

A simple, selective, and precise stability-indicating reversed-phase liquid chromatographic method was developed and validated for the determination of nilotinib. Nilotinib was subjected to acid and alkali hydrolysis, oxidation, thermal, and photo-degradation. The degradation products were well separated from the pure drug. The method was based on isocratic elution of nilotinib and its degradation products on reversed phase C18 column (100 mm × 4.6 mm, 3.5 μm) — Zorbax Eclipse Plus using a mobile phase consisting of 10 mM KH2PO4:acetonitrile (54.5:45.5%, v/v) at a flow rate of 1 mL min−1. Quantitation was achieved with UV detection at 265 nm. Linearity, accuracy and precision were found to be acceptable over the concentration range of 0.1–80 μg mL−1. The drug was found to be susceptible to acid and base hydrolysis but resistant to oxidation, dry heat degradation, and photodegradation. The proposed method was successfully applied to the determination of nilotinib in bulk and in its pharmaceutical preparation.