ABSTRACT

A precise, simple, cost-effective, accurate Ultraviolet spectrophotometric method has been developed for the determination of Nintedanib in the Pharmaceutical dosage form. Nintedanib shows the highest ?max at 379.5 nm. The Nintedanib follows linearity in the concentration range of 0.2-1.0 ?g/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 99.93 %. 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. Keywords: Nintedanib, Validation, Ultraviolet spectroscopy, Method development
Publication date: 01/04/2023

https://ijbpas.com/pdf/2023/April/MS_IJBPAS_2023_7014.pdf

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https://doi.org/10.31032/IJBPAS/2023/12.4.7014