Development and Validation of UV Spectrophotometric Method for Determination of Tepotinib in Bulk and Pharmaceutical Dosage Forms

Abstract

The aim of this study was to develop a new, rapid and highly sensitive UV spectrophometer method for the Tepotinib bulk drug. The mobile phase consisted of Water & Acetonitrile in the ration of 50:50v/v and the wavelength to maximum absorbance at 256.0 nm. Analytical calibration curves were linear within a concentration range from 2.5 to 15µg/ml and coefficient of correlation 0.999. %RSD was found to be less than 2. The result of analysis has been validated statistically. This method will be validated in accordance with ICH requirements included the linearity, precision, accuracy sensitivity, and specificity. Hence the proposed method can be used for the reliable quantification of Tepotinib in tablet formulation.