HPLC Analysis of Tylenol Severe Cold and Flu Formulation on Coresep 100 Mixed-Mode Column

Application description

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.

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