HPLC Analysis of Musinex DM Severe Congestion and Cough Formulation on Heritage MA Mixed-Mode Column

Application description

Most of the over-the-counter cold and cough remedies contain a complex mixture of basic, acidic, neutral, hydrophilic, and hydrophobic compounds. Analysis of drugs and counterions usually require two methods - one for the active drug and related impurities and another one for analysis of counterions. The method can be simplified by switching to mixed-mode stationary phases. Mixed-mode stationary phases have ion-pairing reagent attached to the surface of silica gel. The presence of ionizable groups on the surface allows us to achieve 2-D separation on a single column. We have developed a reliable, robust high-efficiency method for analysis of active and inactive ingredients of Mucinex on Heritage MA mixed-mode column. The active ingredients of the formulation include guaifenesin and dextromethorphan. Guaifenesin is a hydrophilic organic compound that is used as a drug that is used to help to remove mucus from the mouth due to the common cold and flu. Dextromethorphan is a hydrophobic basic compound, which is used as an over-the-counter cough suppressant. Excipients are hydrophilic and hydrophobic in nature and are added to improve taste and increase the stability of the formulation. Heritage MA column shows exceptional peak shape and does not demonstrate poor peak shape for basic analytes like dextromethorphan. Heritage MA column can be used for analysis and validation of methods for separation of hydrophobic, hydrophobic basic, hydrophobic acidic and hydrophilic acidic compounds. There are several mechanisms available to be used with this column - reversed-phase, anion-exchange, cation-exclusion, and combination of the above.

Conditions of Experiment
Column: Heritage MA
Separation Modes: reversed-phase, cation-exclusion, anion-exchange
Column Dimenstions: 4.6x150 mm, 3 um, 100A
Mobile Phase: 8% ACN with 30 mM NaH2PO4 pH 3.1
Detection: UV 255
Sample: various
Injection: 3 uL
Flow rate: 1 ml/min
Class of compounds: Amines, Aromatic base, Aromatic compound, Drug, Inorganic anion, Organic acid
Nature of compounds: Acidic, Basic, Hydrophilic, Hydrophobic, Neutral, Polar
Compounds: Bromide ion, Dextromethorphan, Guaifenesin