title: A comparative study of progressive versus successive spectrophotometric resolution techniques applied for pharmaceutical ternary mixtures.
abstract: This work represents a comparative study of a novel progressive spectrophotometric resolution technique namely, amplitude center method (ACM), versus the well-established successive spectrophotometric resolution techniques namely; successive derivative subtraction (SDS); successive derivative of ratio spectra (SDR) and mean centering of ratio spectra (MCR). All the proposed spectrophotometric techniques consist of several consecutive steps utilizing ratio and/or derivative spectra. The novel amplitude center method (ACM) can be used for the determination of ternary mixtures using single divisor where the concentrations of the components are determined through progressive manipulation performed on the same ratio spectrum. Those methods were applied for the analysis of the ternary mixture of chloramphenicol (CHL), dexamethasone sodium phosphate (DXM) and tetryzoline hydrochloride (TZH) in eye drops in the presence of benzalkonium chloride as a preservative. The proposed methods were checked using laboratory-prepared mixtures and were successfully applied for the analysis of pharmaceutical formulation containing the cited drugs. The proposed methods were validated according to the ICH guidelines. A comparative study was conducted between those methods regarding simplicity, limitation and sensitivity. The obtained results were statistically compared with those obtained from the official BP methods, showing no significant difference with respect to accuracy and precision.
authors.affiliation: Analytical Chemistry Department, Faculty of Pharmacy, October University for Modern Sciences and Arts (MSA), 11787 6th October City, Egypt. Electronic address: drsarahsalah@gmail.com.
authors.forename: Sarah S
authors.initials: SS
authors.lastname: Saleh
authors.affiliation: Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr-El Aini Street, 11562 Cairo, Egypt.
authors.forename: Hayam M
authors.initials: HM
authors.lastname: Lotfy
authors.affiliation: Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr-El Aini Street, 11562 Cairo, Egypt.
authors.forename: Nagiba Y
authors.initials: NY
authors.lastname: Hassan
authors.affiliation: Analytical Chemistry Department, Faculty of Pharmacy, October University for Modern Sciences and Arts (MSA), 11787 6th October City, Egypt.
authors.forename: Hesham
authors.initials: H
authors.lastname: Salem
mesh_terms: D002701:Chloramphenicol / Q000737:chemistry; D003907:Dexamethasone / Q000737:chemistry; D004339:Drug Compounding; D007093:Imidazoles / Q000737:chemistry; D012015:Reference Standards; D015203:Reproducibility of Results; D013053:Spectrophotometry / Q000379:methods*
chemical_list: D007093:Imidazoles; D002701:Chloramphenicol; D003907:Dexamethasone; C005810:tetrahydrozoline
keywords: Amplitude center method; Chloramphenicol; Dexamethasone; Successive derivative ratio; Successive derivative subtraction; Tetryzoline