Analytical Quality by Design-Based RP-HPLC Method for the Quantification and Stability Assessment of Nilotinib in Bulk and Nanoformulations
1, 1, 1, 1, 1
- 1Department of Pharmaceutical Sciences, Rashtrasant Tukadoji Maharaj Nagpur University, Nagpur, Maharashtra, INDIA.
CORRESPONDENCE
Veena Belgamwar
Department of Pharmaceutical Sciences, Rashtrasant Tukadoji Maharaj Nagpur University, Nagpur, Maharashtra, INDIA.
Received: 15-05-2026; Accepted: 11-08-2026.
Volume 60, Issue 4s · pp. s1740-s1754 · 2026 · DOI: 10.5530/ijper.20264633
ABSTRACT
Background: Nilotinib, a tyrosine kinase inhibitor of the second generation, is susceptible to stress-induced degradation that could undermine therapeutic effectiveness.Materials and Methods: The accelerated stability studies have been performed on both bulk Nilotinib as well as its nanoformulation in an acidic, basic, oxidative, thermal, and photolytic environment following ICH-recommended guidelines. The developed RP-HPLC method showed efficient separation of Nilotinib from its degraded products and thus is proven to be an appropriate stability-indicating analytical method for the analysis of Nilotinib and its nanoformulation. Supporting Fourier-Transform Infrared Spectroscopy (FTIR) analysis offered molecular-level proof of these changes.Results: Degradation processes included amide hydrolysis, dealkylation, oxidative N-oxide formation, thermal rearrangement, and photolytic radical-mediated cleavage. In all conditions of stress, the nanoformulation uniformly showed diminished degradation than the bulk drug, which emphasizes the shielding effect of the carrier matrix.Conclusion: In combination, HPLC and FTIR profiling created a complete degradation map of Nilotinib, highlighting the nanoformulation's improved stability and corroborating its viability for enhanced therapeutic dependability.
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Agade, R., Hussain, U., Zambre, D., Sheikh, S., & Belgamwar, V. (2026). Analytical Quality by Design-Based RP-HPLC Method for the Quantification and Stability Assessment of Nilotinib in Bulk and Nanoformulations. Indian Journal of Pharmaceutical Education and Research, 60(4s), s1740-s1754. https://doi.org/10.5530/ijper.20264633
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