Development and Validation ofUltraviolet-Spectrophotometric Method forDetermination of Neratinib in Bulk Form

Abstract

Background: Neratinib is an irreversible, orally active tyrosine kinase inhibitor used in the treatment of human
epidermal growth factor receptor 2-positive breast cancer. Due to its expanding therapeutic applications, there is
an increasing need for rapid, simple, economical, and reliable analytical methods for the quantitative estimation
of neratinib in bulk and pharmaceutical dosage forms. Objective: The present study aimed to develop and
validate a simple ultraviolet (UV)-spectrophotometric method for the estimation of neratinib in bulk form using
different solvent systems including methanol, dimethyl sulfoxide (DMSO), and 0.1 N hydrochloric acid (HCl).
Methods: The UV spectrum of neratinib was recorded within the range of 200–400 nm, and the drug exhibited a
maximum absorbance (λmax) at 266 nm in 0.1 N HCl. Calibration curves were prepared according to individual
linearity ranges in different solvents. The developed method was validated according to International Council
for Harmonisation guidelines for parameters including linearity, precision, accuracy, robustness, and ruggedness.
Results: The method obeyed Beer–Lambert’s law with high correlation coefficients (R²), particularly in DMSO
(0.998), indicating excellent linearity. Precision studies, including intraday and interday analyses, showed %
relative standard deviation values within acceptable limits, confirming good reproducibility. Accuracy studies
performed through recovery experiments at 80%, 100%, and 120% levels demonstrated satisfactory recovery with
low variability. Robustness and ruggedness studies confirmed the stability and reliability of the method under small
deliberate variations in analytical conditions and across different instrument systems. Conclusion: The developed
UV-spectrophotometric method was found to be simple, precise, accurate, robust, rugged, and economical.
Therefore, it can be effectively employed for routine quantitative analysis of neratinib in bulk drug samples.