ABSTRACT:
Nintedanib is an orally active tyrosine kinase inhibitor widely used for the treatment of idiopathic pulmonary fibrosis, systemic sclerosis-associated interstitial lung disease, and non-small cell lung cancer. Accurate and reliable analytical methods are essential for the identification, quantification, and quality control of this drug in bulk materials and pharmaceutical dosage forms. According to the available literature, several analytical techniques have been reported for the determination of Nintedanib. Therefore, the present review compiles and summarizes the various analytical methods developed for its analysis. Different chromatographic and spectroscopic techniques have been reported for the estimation of Nintedanib, including High Performance Liquid Chromatography (HPLC), Reverse Phase High Performance Liquid Chromatography (RP-HPLC), and other advanced analytical approaches. Among these techniques, chromatographic methods, particularly HPLC, are widely applied due to their high sensitivity, accuracy, and reproducibility. Important parameters involved in analytical method development such as column selection, mobile phase composition, detection wavelength, and chromatographic conditions are discussed. In addition, key validation parameters including linearity, accuracy, precision, limit of detection (LOD), and limit of quantification (LOQ) are reviewed according to the guidelines of the International Council for Harmonisation (ICH) and other regulatory authorities.