Application of High-Performance Thin-layer Chromatographic Method for Simultaneous Determination of Co-formulated Ofloxacin and Racecadotril in their Oral Dosage Form

Abstract

Objectives: This study aimed to develop and validate a simple, rapid, economical, precise and accurate HPTLC method for simultaneous determination of ofloxacin and racecadotril has been developed. Methods: Chromatographic separation was achieved using silica gel aluminum plate 60 F254 (10*10) as a stationary phase and dichloromethane: methanol: tri-ethylamine (95:5:0.1 by volume) as a mobile phase. The developed plates scanned densitometrically using UV detector. Detection was carried out at 254 nm over the concentration range of 100-800 ng/spot for ofloxacin and 30-240 ng/spot for racecadotril. The Rf value of ofloxacin and racecadotril was found to be 0.15 and 0.85 respectively. Results: The method is validated for different validation parameter such as linearity, accuracy, precision, LOD, LOQ and robustness and the result were found to be within the acceptance limit as per the guideline of international conference on harmonization (ICH). Conclusion: The described TLC-densitometric method was successfully applied to simultaneous determination of ofloxacin and racecadotril in their pure forms and pharmaceutical dosage form without previous separation.