title: Validated RP-HPLC and TLC-Densitometric Methods for Analysis of Ternary Mixture of Cetylpyridinium Chloride, Chlorocresol and Lidocaine in Oral Antiseptic Formulation.
abstract: This work was concerned with development, optimization, application and validation of reversed phase high performance liquid chromatography (RP-HPLC) and thin layer chromatography (TLC)-densitometric methods for analysis of cetylpyridinium chloride, chlorocresol and lidocaine in Canyon(®) gel. The first developed RP-HPLC method depended on chromatographic separation on a ZORBAX Eclipse Plus C8 column, with elution with a mobile phase consisting 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 ultraviolet detection at 220 nm. While in the subsequently developed method, the 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 the scanning wavelength. Factors affecting the developed methods were studied and optimized; moreover, methods had been validated as per the International Conference of Harmonization 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.
authors.affiliation: Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Beni-Suef University, Al shaheed Shehata Ahmed Hegazy st., 62514 Beni-Suef, Egypt.
authors.forename: Nada S
authors.initials: NS
authors.lastname: Abdelwahab
authors.affiliation: Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Beni-Suef University, Al shaheed Shehata Ahmed Hegazy st., 62514 Beni-Suef, Egypt.
authors.forename: Nouruddin W
authors.initials: NW
authors.lastname: Ali
authors.affiliation: Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini st., 11562 Cairo, Egypt.
authors.forename: M
authors.initials: M
authors.lastname: Abdelkawy
authors.affiliation: Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Beni-Suef University, Al shaheed Shehata Ahmed Hegazy st., 62514 Beni-Suef, Egypt aml17484@gmail.com.
authors.forename: Aml A
authors.initials: AA
authors.lastname: Emam
mesh_terms: D000097:Acetonitriles; D000891:Anti-Infective Agents, Local / Q000737:chemistry*; D002594:Cetylpyridinium / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid / Q000379:methods / Q000592:standards; D056148:Chromatography, Reverse-Phase / Q000379:methods / Q000592:standards; D002855:Chromatography, Thin Layer / Q000379:methods / Q000592:standards; D003408:Cresols / Q000032:analysis*; D003720:Densitometry / Q000379:methods / Q000592:standards; D004355:Drug Stability; D006801:Humans; D008012:Lidocaine / Q000032:analysis*; D000432:Methanol; D009055:Mouth; D010756:Phosphoric Acids; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012997:Solvents
chemical_list: D000097:Acetonitriles; D000891:Anti-Infective Agents, Local; D003408:Cresols; D010756:Phosphoric Acids; D012997:Solvents; C006984:chlorocresol; D008012:Lidocaine; D002594:Cetylpyridinium; C030242:phosphoric acid; D000432:Methanol; C032159:acetonitrile