World Journal of
Pharmaceutical and Life Sciences

METHOD DEVELOPMENT AND VALIDATION OF NILOTINIB HYDROCHLORIDE MONOHYDRATE BY UV-VISIBLE SPECTROSCOPY

R. Krishnan*, Dr. V. Sekar, N. Mohanapriya, S. Divyadharshini, S. Bagavathy, S. Mounika, S. Shukurullah Ali, and S. Sanjay,

ABSTRACT

This study aimed to develop and validate a simple, cost-effective, and precise UV-visible spectrophotometric method for quantifying nilotinib hydrochloride monohydrate (NHM) in pharmaceutical formulations. The procedure's solvent was acetonitrile (ACN):water (1:1 v/v), and NHM's maximum absorbance was recorded at 303 nm. The method demonstrated excellent linearity in the concentration range of 0–50 μg/mL (R2 = 0.9998), as per the International Council for Harmonization (ICH) guidelines. High reproducibility was shown by precision studies with intra-day and inter-day precision <2% and assay analysis %RSD values of 0.58%. Accuracy was confirmed by recovery studies at 100%, 150%, and 200% levels; recoveries ranging from 99 to 101% (%RSD = 0.612) were obtained. The limits of quantification (LOQ) and detection (LOD) were determined to be 4.719 μg/mL and 1.557 μg/mL, respectively, indicating high sensitivity. The assay of capsule formulations showed a percentage purity of 100.03% w/v, which is in line with the acceptance criteria (90–110%). The created technique demonstrated robustness, specificity, and excipient interference-free operation. This UV-visible spectroscopy method is ideal for routine quality control of NHM in pharmaceutical industries because it offers benefits like simplicity, speed, and cost-effectiveness. It also ensures regulatory compliance and improves analytical efficiency.

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