Doxylamine

Doxylamine C17H22N2O

Doxylamine
 Doxylamine
Select Applications HPLC Analysis of Cough and Cold Medications Active Ingredients and Acidic Counterions on Heritage MA Mixed-Mode Column HPLC Analysis of Alka-Seltzer Plus MAX Sterngth Severe Sinus, Allergy and Cough Formulation on Coresep 100 Mixed-Mode Column HPLC Analysis of Pyridoxal, Pyridoxine, Pyridoxal 5-’Phosphate and Doxylamine on Amaze TH Mixed-Mode Column
HPLC Analysis of Cough and Cold Medications Active Ingredients and Acidic Counterions on Heritage MA Mixed-Mode Column
Application description

There are several groups of compounds which are used as active and inactive ingredients in various over-the-counter drug compositions. These compounds are different in nature and can be organic and inorganic. Most of the active ingredients are either hydrophobic basic, hydrophilic basic or hydrophilic neutral compounds. Basic active ingredients of cough and cold remedies used as salts of organic and inorganic acids. The most commonly used hydrophobic active ingredients are doxylamine, pyrilamine, chlorpheniramine, brompheniramine, and dextromethorphan. Doxylamine is an antihistamine drug, used to relieve symptoms of allergy, hay fever, and the common cold. Doxylamine is used in combination with other active ingredients to provide effective nighttime relief from cough and cold symptoms. Pyrilamine is an antihistamine drug, which targetsH1 receptors as an inverse agonist. Brompheniramine is an antihistamine drug of propylamine nature. Chlorpheniramine is an antihistamine used to treat symptoms such as allergic rhinitis. Dextromethorphan is a medication mostly used as a cough suppressant. It is a morphine type of medication with sedative, dissociative, and stimulant properties. Succinic acid is a hydrophilic diacid that is used as a counterion. Maleic acid is hydrophilic diacid which is used as a counterion. Both compounds have very limited retention even in RP-AQ columns. Due to the strongly hydrophobic and basic properties of these compounds, they demonstrate a poor peak shape in traditional reversed-phase chromatography due to the overloading of residual silanol groups on the surface when these basic drugs are analyzed. In addition to this, hydrophilic counterions are not retained in RP because there is no mechanism of retention for these acidic hydrophilic compounds. Both problems were eliminated by using Heritage MA reversed-phase anion-exchange column. Column and method demonstrate high efficiency and good peak shape for acidic and basic analytes. It can be used to develop methods for various cough, cold, and congestion compositions without the use of ion-pairing reagents. Compounds are well retained by a combination of one or more mechanisms. The column is compatible with 100% ACN and 100% water as well as with most buffers with pH 1.5-7. Various additives to the mobile phase can be used based on the nature of samples and detection techniques.

HPLC Analysis of Cough and Cold Medications Active Ingredients and Acidic Counterions on Heritage MA Mixed-Mode Column chromatogram
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Conditions of Experiment
Column: Heritage MA
Separation Modes: reversed-phase, cation-exclusion, anion-exchange
Column Dimenstions: 4.6x150 mm, 3 um, 100A
Mobile Phase: 5% ACN with 30 mM AmFm pH 3
Detection: UV 275
Sample: various
Injection: 3 uL
Flow rate: 1 ml/min
Analytes
Class of compounds: Amines, Aromatic base, Drug, Organic acid, Pyridine
Nature of compounds: Acidic, Basic, Hydrophilic, Hydrophobic, Polar
Compounds: Doxylamine, Pyrilamine, Succinic acid, Chlorpheniramine, Brompheniramine, Maleic acid, Dextromethorphan
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).

HPLC Analysis of Alka-Seltzer Plus MAX Sterngth Severe Sinus, Allergy and Cough Formulation on Coresep 100 Mixed-Mode Column chromatogram
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Conditions of Experiment
Column: Coresep 100
Separation Modes: reversed-phase, cation-exchange
Column Dimenstions: 4.6x150 mm, 2.7 um, 90A
Mobile Phase: "A: 10% ACN with 0.02% H2SO4
B: 70% ACN with 0.2% H2SO4
from 100% A to 100% B in 8 min, 4 min hold "
Detection: UV 275
Sample: various
Injection: 3 uL
Flow rate: 1 ml/min
Analytes
Class of compounds: Amines, Aromatic base, Aromatic compound, Catecholamine, Drug, Neurotransmitter
Nature of compounds: Basic, Hydrophilic, Hydrophobic, Neutral, Polar
Compounds: Acetaminophen, Phenylephrine, Doxylamine, Dextromethorphan
HPLC Analysis of Pyridoxal, Pyridoxine, Pyridoxal 5-’Phosphate and Doxylamine on Amaze TH Mixed-Mode Column
HPLC Analysis of Pyridoxal, Pyridoxine, Pyridoxal 5-’Phosphate and Doxylamine on Amaze TH Mixed-Mode Column chromatogram
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Conditions of Experiment
Column: Amaze TH
Separation Modes: HILIC, cation-exchange
Column Dimenstions: 4.6x50 mm, 3 um, 100A
Mobile Phase: 80% ACN with 30 mM AmFm pH 3.5
Detection: UV 255 nm
Sample: 0.3 mg/ml
Injection: 5 uL
Flow rate: 1 ml/min
Analytes
Class of compounds: Aromatic base, Drug, Vitamin
Nature of compounds: Basic, Hydrophilic, Hydrophobic, Polar, Zwitterionic
Compounds: Doxylamine, Pyridoxal, Pyridoxine, Pyridoxal 5′-phosphate