HPLC Analysis of Alka-Seltzer Plus MAX Sterngth Severe Sinus, Allergy and Cough Formulation on Coresep 100 Mixed-Mode Column

Application description

Alka-Seltzer Plus MAX Strength Severe Sinus is a complex mixture of active ingredients and excipients. It is used in the treatment of cough, stuffy nose, body aches, headache, and a sore throat caused by common cold and flu. The active ingredients include acetaminophen, phenylephrine, doxylamine, and dextromethorphan. Inactive ingredients and excipients include D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide. These components are different in nature. Acetaminophen is a neutral relatively hydrophobic compound, doxylamine is a basic hydrophobic compound. Dextromethorphan is a hydrophobic basic compound. Phenylephrine is a hydrophilic basic compound. Excipients are polar in nature with some acidic and basic additives. Analysis of such complex mixtures is a difficult task and requires a different methodology. We have developed a robust and reproducible method for the analysis of these drugs, impurities, and excipients. Baseline HPLC separation is achieved on Corespe 100 mixed-mode reversed-phase cation-exchange core-shell column. Column demonstrates good peak shape and retention control. Unique selectivity of mixed-mode columns allows controlling the retention of compounds of different nature independently by changing mobile phase composition. The selectivity of the separation controlled by the amount of ACn, buffer concentration, and buffer pH. Various buffers and acids can be used as additives to the mobile phase. The choice of the buffer depends on the detection technique and properties of the column and analytes. Core-shell mixed-mode columns offer unprecedented selectivity associated with multi-mode interactions and high efficiency of core-shell particles. Compounds are well retained without the use of ion-pairing reagent. The column is compatible with 100% water and 100% ACN. Other drug formulation can be analyzed on mixed-mode columns with perfect peak shape, retention control, and robustness. Coresep 100 columns can be used with any of the common detection techniques (UV, ELSD, RI, mass-spec, CAD).