Stability Indicating UV-Visible Spectrophotometric Method for the Estimation of Flunarizine Dihydrochloride Through Second-Order Derivative Spectroscopy

Abstract

The presented study is a simple, precise and accurate stability-indicating second-order UV derivative spectroscopic method that is being studied under the different stated International Council for Harmonization (ICH) Guidelines because of its forced-degradation properties, and to establish a validating method for Flunarizine dihydrochloride in active pharmaceutical ingredients (API). Adhering to ICH guidelines, the analytical parameters, viz. linearity, range, precision, and accuracy, were validated. The method was based on thorough stress testing utilizing acid, base, thermal, photolytic and oxidative degradations, and it was found that a linear response is present in the concentration range of 10–60 μg/mL at 253 nm. The % relative standard deviation (RSD) for precision studies of interday and intraday were <1.29 and <1.17%, respectively. The developed analytical method for validating flunarizine dihydrochloride using second-order derivative spectroscopy is found to be simple and precise, and the percentage recovery was found to be within acceptable limits. It can be conveniently used for routine analysis. In the forced degradation studies of flunarizine dihydrochloride utilizing various parameters, such as acid, alkali, light and heat, the absorbance of the drug was noted to have decreased approximately 10% in both the formulation and the standard. Based on the results obtained, it was found that the proposed method is accurate, precise, and reproducible, and can be employed for quality control analysis.