Phenylephrine

Robitussin Severe Cough, Cold & Flu Formulation is a complex mixture of organic and inorganic compounds. The main active drug ingredients are acetaminophen, phenylephrine, guaifenesin, and dextromethorphan. Inactive ingredients include anhydrous citric acid, edetate disodium, FD&C red no. 40, glycerin, menthol, natural and artificial flavors, polyethylene glycol, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, triacetin, xanthan gum. Acetaminophen or paracetamol is a relatively hydrophilic drug, which is used to treat pain and fever. Phenylephrine is a hydrophilic basic drug, which is primarily used as a decongestant, to dilate the pupil, to increase blood pressure, and to relieve hemorrhoids. Guaifenesin is a hydrophilic organic compound which 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 stability of the formulation. Several complex methods are required to fully analyze this drug composition. We have developed a simple UV method using Coresep 100 mixed-mode column. Coresep 100 column is a reversed-phase cation-exchange column, based on 2.7 um core-shell articles. It is designed to retain various analytes without the use of ion-pairing reagents. This approach makes these columns fully compatible with mass spec detection. The method for analysis of this drug formulation is reproducible and robust and provides baseline separation of hydrophobic basic, hydrophilic basic, neutral, hydrophobic, and hydrophobic acidic compounds. Hydrophilic acidic compounds might not be retained. The column is compatible with 100% water and 100% ACN and totally resistant to phase collapse, due to polar-embedded ionizable groups on the surface of core-shell particles. Mixed-mode HPLC columns provide 2-D selectivity for the retention of hydrophobic and hydrophilic ionizable compounds.

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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 0.03% H2SO4 B: 55% ACN with 0.25% 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, Guaifenesin, Dextromethorphan

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).

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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

Tylenol Severe Cold and Flu formulation includes active ingredients as well as excipients. Active components include acetaminophen, phenylephrine, guaifenesin, and dextromethorphan. Inactive ingredients include carnauba wax, croscarmellose sodium, D&C yellow no. 10 aluminum lake, flavor, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sucralose, titanium dioxide. The complex mixture of hydrophobic, hydrophilic, basic, acidic, and neutral components of Tylenol medication was fully separated on Coresep 100 mixed-mode core-shell reversed-phase cation-exchange column. The method is robust and reproducible and can be used for the analysis of drugs and drug compositions in various sample matrices. Various buffers and additives to the mobile phase can be used depending on the detection technique. The retention time of active ingredients, impurities, and excipients is controlled by the amount of acetonitrile (ACN), buffer pH, and buffer concentration. Core-shell columns provide very high efficiency of separation and mixed-mode provides unique selectivity and ability to retain hydrophilic compounds without the use of ion-pairing reagents. Mixed-mode columns are compatible with 100% ACN and 100% water due to the presence of polar and ionizable groups on the surface of silica gel. The column can be effectively used in isocratic and gradient runs to achieve baseline resolution between various active and inactive ingredients.

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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 0.03% H2SO4 B: 70% ACN with 0.25% 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, Guaifenesin, Dextromethorphan

Dimetapp Cold & Cough for kids is a liquid medicine containing three active ingredients: a nasal decongestant (Phenylephrine HCI), an antihistamine (Brompheniramine maleate) and a cough suppressant (Dextromethorphan HBr). There are multiple excipients in the formulation for the flavor, thickness, and preservation. The nasal decongestant works to temporarily restore free breathing through the nose to help clear a stuffy nose. The antihistamine/cough suppressant in this liquid cough medicine is tough on common upper respiratory symptoms like runny nose, sneezing, itchy, watery eyes, and itching of the nose or throat, as well as coughing due to minor throat irritation. Phenylephrine is a hydrophilic basic compound with poor retention in reversed-phase chromatography. Brompheniramine is a hydrophobic basic compound with strong retention and poor peak shape on traditional reversed-phase columns. Dextromethorphan is a hydrophobic basic compound with strong retention and poor peak shape when reversed-phase columns are used. We have developed a simple but robust method for analysis of active ingredients and excipients of Dimetapp formulation. All active compounds and excipients are retained and separated by several mechanisms - reversed-phase, cation-exchange, and anion-exclusion. Inactive ingredients in the formulation include Anhydrous Citric Acid, Artificial Flavor, Fd&C Blue No. 1, Fd&C Red No. 40, Glycerin, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sorbitol Solution, Sucralose. The retention of compounds is adjusted by changing the amount of ACN, buffer pH, and buffer concentration. The method can be applied to the analysis of drugs in biofluids. Most common detection techniques can be used (UV, ELSD, mass-spec, etc.). Core-shell columns provide very high efficiency of separation and mixed-mode provides unique selectivity and ability to retain hydrophilic compounds without the use of ion-pairing reagents.

Coresep 100 PURCHASE LEARN ABOUT Coresep 100

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, Catecholamine, Drug, Neurotransmitter
Nature of compounds:	Basic, Hydrophilic, Hydrophobic, Polar
Compounds:	Phenylephrine, Dextromethorphan, Brompheniramine