Diphenhydramine

HPLC Analysis of Wal-Dryl Allergy & Sinus Headache Formulation on Coresep 100 Mixed-Mode Column
Application description

Cold and cough remedies sold over the counter consist of several active and inactive ingredients, which are different in nature and resin differently in reversed-phase, ion-exchange, and HILIC chromatography. Wal-Dryl is a white label composition sold by Walgreens. Active Ingredients include Acetaminophen (325 mg), Diphenhydramine HCl (25 mg), Phenylephrine HCl (5 mg). Inactive Ingredients in this complex composition are Corn Starch, Croscarmellose Sodium, Crospovidone, FD&C Blue #1 Aluminum Lake, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Silica Gel, Stearic Acid, Titanium Dioxide, Triacetin. Mixed-mode HPLC columns allow retaining hydrophobic and hydrophilic, neutral and charged compounds in one run. Retention of polar basic compounds does not require the use of ion-pairing reagents (IP) to achieve controllable robust retention control. Order of elution for active and inactive ingredients in the complex mixture can be changed and adjusted with the pH of the mobile phase, as well as the amount of ACN and buffer. Coresep 100 retains and separates components of Wal-Dryl cold remedies with high efficiency and robustness. Acetaminophen or paracetamol is a relatively hydrophilic drug, which is used to treat pain and fever. Pseudoephedrine is a sympathomimetic medication in the phenylamine and amphetamine class of drugs. It is a stimulant. Pseudoephedrine is a part of numerous drug formulations used as cough suppressants. It is used as a precursor and starting material in the illicit production of methamphetamine and methcathinone. Pseudoephedrine is polar and basic in nature. Diphenhydramine is an antihistamine that reduces the effects of the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose. Diphenhydramine is used to treat sneezing, runny nose, watery eyes, hives, skin rash, itching, and other cold or allergy symptoms. Diphenhydramine is hydrophobic and basic in nature compound. Excipients are hydrophilic and hydrophobic in nature and are added to improve taste and increase the stability of the formulation

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: Aromatic base, Aromatic compound, Drug, Stimulant
Nature of compounds: Basic, Hydrophilic, Hydrophobic, Neutral
Compounds: Acetaminophen, Pseudoephedrine, Diphenhydramine