Development and Validation of a UV-Spectrophotometric method for the Estimation of Nintedanib Esylate in Bulk and its Formulation

Abstract

The present work represents a UV spectrophotometric method for the estimation of Nintedanib Esylate in pure and its formulation. Methanol was used as a solvent. Nintedanib Esylate exhibit absorption maxima at 391 nm. The developed method obeyed Beer-Lambert’s law in the concentration range of 3-18 µg/ml having a line equation Y = 0.065x + 0.001 with a correlation coefficient of 0.999. There is no interference from any pharmaceutical excipients. The precision of the method was determined by performing the intra-day study and inter-day study. The accuracy of the method was confirmed by recovery studies from capsules at three different levels by standard additions. Results of the analysis were validated statistically and by recovery study. The analytical method was validated for various parameters as per ICH (International Conference on Harmonization) guidelines. The proposed method was found to be simple, rapid, accurate and precise and can be applied for the routine quality control studies for assay of Nintedanib Esylate in pure and its formulation.

Keywords: ICH guidelines, Method validation, Nintedanib Esylate, UV-Spectrophotometric

Cite this Article

Rohan S. Patil, Moreshwar P. Mahajan. Development and Validation of a UV-Spectrophotometric method for the Estimation of Nintedanib Esylate in Bulk and its Formulation. Research and Reviews: A Journal of Pharmaceutical Science. 2018; 9(2): 49–53p