Year: 2018
Title: Development and optimization of a generic HPLC method for the simultaneous determination of common ingredients in multi component cough and cold oral drug products using chemometrics
Author: Zafirova, Marija
Author: Acevska, Jelena
Author: Ugrinova, Liljana
Author: Petrovska-Dimitrievska, Gabriela
Author: Karchev, Vasil
Author: Nakov, Natalija
Author: Brezovska, Katerina
Author: Dimitrovska, Aneta
Author: Petkovska, Rumenka
Author: Anastasova, Liljana
Author: Tonic-Ribarska, Jasmina
Author: Poceva Panovska, Ana
Author: Kavrakovski, Zoran
Author: Trajkovic-Jolevska, Suzana
Abstract: The aim of this work was to develop a single, generally applicable high performance liquid chromatography/diode array detector (HPLC/DAD) method for simultaneous determination of the most frequently used cough and cold active substances and their impurities that would be applicable for a number of possible formulation compositions of cough and cold medicines. The compounds that are separated by the method include eleven active substances: paracetamol, phenylephrine HCl, caffeine, ibuprofen, ascorbic acid, propiphenazone, pheniramine maleate, chlorphenamine maleate, pseudoephedrine HCl, dextromethorphan HBr and cetylpyridinium Cl; five of their impurities: 4-aminophenol, 4-nitrophenol, 4`-chloroacetanilide, chlorphenamine impurity C and ephedrine HCl; and two preservatives: sodium benzoate and propyl parahydroxybenzoate. All 18 compounds were successfully separated on a reversed phase (RP)-HPLC column with superficially porous particles using gradient elution with a very simple mobile phase in 14 minutes with excellent sensitivity and resolution. Method optimization was performed by the design of experiments approach. The proposed method has been validated according to ICH guidelines and proved to be suitable for the simultaneous qualitative and quantitative determination of the selected compounds in different cough and cold dosage forms. Keywords: cough and cold active substances and impurities, HPLC/DAD, superficially porous particles, core-shell particles, chemometrics, design of experiments
Publisher: Macedonian Pharmaceutical Association
Relation: Macedonian Pharmaceutical Bulletin
Identifier: oai:repository.ukim.mk:20.500.12188/23694
Identifier: http://hdl.handle.net/20.500.12188/23694Identifier: 10.33320/maced.pharm.bull.2017.63.02.006
Identifier: http://bulletin.mfd.org.mk/volumes/Volume%2063_2/63_2_006.pdfIdentifier: 63
Identifier: 02
