title: A new hydrophilic interaction liquid chromatographic (HILIC) procedure for the simultaneous determination of pseudoephedrine hydrochloride (PSH), diphenhydramine hydrochloride (DPH) and dextromethorphan hydrobromide (DXH) in cough-cold formulations.
abstract: A new HILIC method has been developed for the simultaneous determination of pseudoephedrine hydrochloride (PSH), diphenhydramine hydrochloride (DPH) and dextromethorphan hydrobromide (DXH) in cough-cold syrup. Mobile phase consists of methanol:water (containing 6.0 g of ammonium acetate and 10 mL of triethylamine per liter, pH adjusted to 5.2 with orthophosphoric acid), 95:5 (v/v). Column containing porous silica particles (Supelcosil LC-Si, 25 cm x 4.6 mm, 5 microm) is used as stationary phase. Detection is carried out using a variable wavelength UV-vis detector at 254 nm for PSH and DPH, and at 280 nm for DXH. Solutions are injected into the chromatograph under isocratic condition at constant flow rate of 1.2 mL/min. Linearity range and percent recoveries for PSH, DPH and DXH were 150-600, 62.5-250, 75-300 microg/mL and 100.7%, 100.1% and 100.8%, respectively. Method is stability indicating and excipients like saccharin sodium, sodium citrate, flavour and sodium benzoate did not interfere in the analysis. Compounds elute in order of increasing ionization degree caused by cation-exchange mechanism in a run time of less than 15 min. Mobile phase pH is manipulated to regulate ionization and ion-exchange interaction and thereby retention of compounds.
authors.affiliation: Jamjoom Pharmaceuticals Company Limited, Industrial Area, Phase-5, Jeddah 21442, Saudi Arabia. msali26@rediffmail.com
authors.forename: Mohammed Shahid
authors.initials: MS
authors.lastname: Ali
authors.forename: Mohsin
authors.initials: M
authors.lastname: Ghori
authors.forename: Syed
authors.initials: S
authors.lastname: Rafiuddin
authors.forename: Aamer Roshanali
authors.initials: AR
authors.lastname: Khatri
mesh_terms: D000085:Acetates / Q000737:chemistry; D000996:Antitussive Agents / Q000032:analysis*; D002021:Buffers; D055598:Chemical Phenomena; D002627:Chemistry, Physical; D002851:Chromatography, High Pressure Liquid; D003915:Dextromethorphan / Q000032:analysis*; D004155:Diphenhydramine / Q000032:analysis*; D004338:Drug Combinations; D004809:Ephedrine / Q000032:analysis*; D006634:Histamine H1 Antagonists / Q000032:analysis*; D006863:Hydrogen-Ion Concentration; D007202:Indicators and Reagents; D014663:Nasal Decongestants / Q000032:analysis*; D019999:Pharmaceutical Solutions; D012015:Reference Standards; D015203:Reproducibility of Results; D012997:Solvents; D013056:Spectrophotometry, Ultraviolet
chemical_list: D000085:Acetates; D000996:Antitussive Agents; D002021:Buffers; D004338:Drug Combinations; D006634:Histamine H1 Antagonists; D007202:Indicators and Reagents; D014663:Nasal Decongestants; D019999:Pharmaceutical Solutions; D012997:Solvents; D003915:Dextromethorphan; D004155:Diphenhydramine; D004809:Ephedrine; C018824:ammonium acetate