ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF CINNARIZINE BY UV-VISIBLE SPECTROSCOPY

Abstract

Abstract
The present study focuses on the development and validation of a simple, rapid, accurate, and cost-effective UV–Visible spectrophotometric method for the estimation of Cinnarizine in pharmaceutical formulations. Cinnarizine, an antihistaminic and antivertigo drug, was analyzed using Acetonitrile and 0.1N HCl (30:70 v/v) as the solvent system. The drug exhibited maximum absorbance (λmax) at 255 nm, and the method obeyed Beer–Lambert’s law within the concentration range of 10–50 µg/mL with a correlation coefficient (R²) of 0.9998. The developed method was validated according to ICH guidelines for parameters such as linearity, precision, accuracy, limit of detection (LOD), and limit of quantification (LOQ). The assay of marketed tablet formulation showed a percentage purity of 100.15% with %RSD below 2%, indicating excellent precision and reproducibility. Recovery studies at 100%, 150%, and 200% levels demonstrated satisfactory accuracy with recoveries ranging between 99–101%. The LOD and LOQ values were found to be 0.44 µg/mL and 1.33 µg/mL, respectively, confirming the sensitivity of the method. The proposed analytical method was found to be reliable, precise, sensitive, and suitable for routine quality control analysis of Cinnarizine in pharmaceutical dosage forms.
Keywords:
Cinnarizine, UV–Visible Spectroscopy, Method Validation, Pharmaceutical Analysis, ICH Guidelines, Spectrophotometric Method