Validated RP-HPLC and TLC-densitometric Methods for Analysis of Ternary Mixture of Cetylpyridinium Chloride, Chlorocresol, and Lidocaine in Oral Antiseptic Formulation

Research Abstract

This work was concerned with development, optimization, application, and validation of RP-HPLC and TLC-densitometric chromatographic methods for analysis of cetylpyridinium chloride, chlorocresol, and lidocaine in Canyon® gel. The firstly developed RP-HPLC method depended on chromatographic separation on a ZORBAX Eclipse Plus, C8 column, elution with a mobile phase consisted of 0.05% phosphoric acid solution: acetonitrile: methanol (15: 24: 61, by volume), pumping the mobile phase at a flow rate of 1.00 ml min-1 with UV detection at 220 nm. While in the secondly developed chromatographic method, TLC-densitometric method, complete separation of the studied mixture was achieved using methanol: acetone: acetic acid (7: 3: 0.2, by volume) as a mobile phase, aluminum plates precoated with silica gel 60 F254 as a stationary phase, and 215 nm as a scanning wavelength. Factors affecting the developed methods were studied and optimized, moreover, methods had been validated as per ICH guideline and the results indicated that the suggested methods were reproducible, reliable, and applicable for rapid routine analysis. Statistical comparison of the two developed methods with the reported HPLC ones using F and student's-t tests showed no significant difference

Research Keywords

Cetylpyridinium chloride; Chlorocresol; Lidocaine; RP-HPLC; TLC-densitometry