Validated uv-spectrophotometric method for quantitative estimation of ciclopirox olamine in API and ethosomal gel

Abstract

Ultra-visible Spectroscopy is one of the most widely used analytical techniques in pharmaceutical research, university's, industries and quality control laboratories. This technique offers high sensitivity, accuracy, precision, and reproducibility, providing huge platform for drug discovery, development, and routine quality assurance. This short communication presents a comprehensive overview of Ultra-visible Spectroscopy, method development strategies, validation parameters as per International Council for Harmonisation (ICH) guidelinesQ2(R2) for the determination of Ciclopirox olamine in API as well as Ethosomal gel. Ultra Violet-Spectroscopy process developed for Ciclopirox Olamine shows the maximum absorbance at wavelength 302 nm. Ciclopirox Olamine showed the linearity, range 2.5–25 µg per ml for this procedure with Correlation Coeff. (R²) found to be 0.9996. The technique was found definite as no intervention was detected with excipients. The precision studies include Repeatability, Inter-day Precision, Intra-day Precision, Specificity and Accuracy studies and their R.S.D value found to be 0.98,1.55,1.448,0.032 and 0.27. (Acceptable criteria: RSD should be less than 2%). The proposed analytical process is suggested for analysis of Ciclopirox olamine as API and ethosomal dosage forms. This article aims to serve as a useful reference for researchers, academicians, and quality control analysts involved in pharmaceutical analysis. UV–Visible spectroscopy is widely used in pharmaceutical analysis due to rapid analysis, cost effective, minimal solvent consumption and non-destructive technique.