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

Autor: Aneta Dimitrovska, Marija Zafirova, Ana Poceva Panovska, Suzana Trajkovic-Jolevska, Gabriela Petrovska-Dimitrievska, Jelena Acevska, Liljana Anastasova, Zoran Kavrakovski, Vasil Karchev, Jasmina Tonic-Ribarska, Katerina Brezovska, Liljana Ugrinova, Rumenka Petkovska, Natalija Nakov
Rok vydání: 2018
Předmět:
Zdroj: Macedonian Pharmaceutical Bulletin. 63:49-65
ISSN: 1857-8969
1409-8695
DOI: 10.33320/maced.pharm.bull.2017.63.02.006
Popis: 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
Databáze: OpenAIRE
Externí odkaz: