Analysis of Epalrestat in Bulk and Tablet Formulation by Difference Spectrometry

Author(s)

Patel, C. D., Patel, R. J., Mardia, R. B., Chauhan, S. P., Suhagia, B. N.

Author's Affiliation

Abstract

A simple, rapid, sensitive and cost effective Difference spectrophotometric method has been developed for the analysis of Epalrestat in bulk and its tablet formulation using two different pH conditions produced by 0.1N HCl (acidic) and 0.1N NaOH (basic). The spectral characteristics of Epalrestat were found to be different in acidic and basic medium. For the difference spectrophotometry, the difference spectra of Epalrestat was scanned in the UV - Visible spectrophotometer between 200 - 800nm by putting acidic solution of  Epalrestat in the sample cell and basic solution of the same concentration of Epalrestat in the reference cell. Difference spectra showed the difference absorbance of Epalrestat between basic and acidic conditions. The proposed method was validated according to ICH guideline. Beers’ law was obeyed in the concentration range of 1-6 μg/ml at 404 nm which was selected as an analytical wavelength for determination. The correlation co-efficient was found to be 0.9980. The % recovery of Epalrestat was in the range of 96 - 104.4%.  The coefficient of variance for intraday and interday precision was found to be 0.207 - 1.98 and 0.912 - 1.43 respectively. Limit of detection and limit of quantification were 0.482 µg/ml and 1.462 µg/ml respectively. The proposed method was applied for determination of Epalrestat in the marketed formulation in which % assay was found to be 104.5%. The method was found to be, accurate, precise, repeatable and specific.

Keywords

Epalrestat, HCl, NaOH, Difference spectrophotometry

Cite This Article

Patel, C. D., Patel, R. J., Mardia, R. B., Chauhan, S. P., & Suhagia, B. N. (2014). Analysis of Epalrestat in Bulk and Tablet Formulation by Difference Spectrometry. International Journal for Pharmaceutical Research Scholars (IJPRS), 3(2), 586-590.