Novel Rapid Validated TLC- Densitometry for the Simultaneous Determination of Three Co-formulated Drugs used for Deep Tooth Inflammation Treatment

Abstract

A new use of a tertiary antibiotic combination of ciprofloxacin, clindamycin and metronidazole is currently being studied as an intracranial (intracranial) drug in an effort to disinfect the root canal system to revitalize the tooth with dead pulp. It is necessary to developing analytical method for the new drug combination. Herein we developed a rapid validated thin-layer chromatography (TLC)‒densitometric method has been developed for the simultaneous determination of 3 co-formulated drugs used for deep tooth inflammation Treatment. The studied drugs are Ciprofloxacin.HCL (CIP), Clindamycin phosphate (CLI) and Metronidazole(MET). The separation was achieved by using silica gel 60 F254 plates (20*20 cm) as stationary Phase and the developing system of Dichloromethane:n-Hexane:methanol:Ethylamine:Triethylamine (40:20:32:3:5)v/v. Densitometry scanning was performed at 220 nm. The Rf values of CIP, CLI and MET were found to be 0.588, 0.776 and 0.898 respectively. The method was validated as per the International Conference on Harmonization (ICH) guidelines and was successfully applied for the analysis of ternary lab made mixture, containing the cited ternary mixture without interference from excipients. There is no previously published TLC–densitometry method for the determination of the previously mentioned ternary mixture. The suggested method is novel, rapid, accurate, reproducible and of low cost, so; thus, it can be used for quality control analysis of these formulations.