Development And Validation Of UV Spectrophotometric Method For The Determination Of Nintedanib In Pharmaceutical Dosage Form

Abstract

A precise, simple, cost-effective, accurate Ultraviolet spectro-photometric method has been developed for the determination of Nintedanib in the Pharmaceutical dosage form. Nintedanib shows the highest λmax at 270nm. The Nintedanib follows linearity in the concentration range of 2.0-12.0 μg/mL with a superior correlation coefficient value of 0.9999. The precision of the method was studied in intra-day and inter-day studies. The % RSD value is < 2 which indicates that the method is precise. The % recovery was found to be in the range lies between 99.75-99.85 %. The percentage assay of Nintedanib obtained was 99.33 %. The Proposed Spectrophotometric method was validated as per the ICH Q2 (R1) guidelines. The developed UV method is accurate, precise, and reproducible. Hence this rapid method can be feasible for the quality control analysis of Nintedanib in the pharmaceutical dosage form.