ABSTRACT

The purpose of the study is to develop and validate a simple, sensitive, and accurate UV spectrophotometric method for the quantification of Dalfampridine in bulk drug and its pharmaceutical dosage form employing multivariate linear regression analysis. Multivariate linear regression analysis was based on the relationship between concentration and absorbance, where the absorbance was measured from five distinct wavelengths, and the results were obtained statistically. The developed approach was linear throughout a concentration range of 5-15 ?g/mL, with a correlation coefficient value greater than 0.998. The Absorption maximum (?max) of Dalfampridine was observed at 244 nm. The developed method was found to be simple, rapid, accurate, and precise in accordance with the ICH guidelines Q2(R1). This approach using statistics gives reliable results without any deviations coming out of the instrument or by experimental conditions. Keywords: Dalfampridine, Multivariate Linear Regression Analysis, Validation, UV Spectrophotometry
Publication date: 01/09/2023

https://ijbpas.com/pdf/2023/September/MS_IJBPAS_2023_7366.pdf

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https://doi.org/10.31032/IJBPAS/2023/12.9.7366