Development of a UPLC Method for Phenylephrine Containing Formulations

Library Number:
WA60007
Part Number:
WA60007
Author(s):
Diane M. Diehl; Fang Xia; Jie Cavanaugh; Paula Hong; Jeffrey R. Mazzeo (Waters)
Source:
AAPS 2006; November 1; San Antonio TX
Content Type:
Posters
Content Subtype:
AAPS
Compounds:
4-Aminophenol; Maleic acid; Fumaric acid; Phenylephrine; Acetaminophen; Phenylpropranolamine; Pheniramine; Doxylamine; Pseudoephedrine; Pyrilamine; Chlorpheniramine; Brompheniramine; Guaifenesin; Acetylsalicylic acid; 4-Nitrophenol; 4-Chloroacetanilide; Dextromethorphan; Diphenhydramine; Clemastine; Ibuprofen
Matrix:
Pharmaceutical formulations including: VICKS® NyQuil®; Children''s Benadryl-D™ Allergy and Sinus; CVS® Pharmacy Children''s TRIACTIN Cough & Runny Nose
Column:
ACQUITY UPLC™ HSS T3 1.8 µm N/A 2.1 mm 100 mm
Related Products:
 
 
Forced Degradation
 

Purpose:

To develop an UPLC method for phenylephrine- and pseudoephedrine-containing formulations utilizing a new column chemistry for polar retention.

Methods:

Standards of common cold and allergy medicine active ingredients and published degradants/impurities were combined into one mixture to cover all possible formulation compositions. Using the ACQUITY UPLC system and MS/MS and UV detection, various separations were developed on a new UPLC column chemistry designed to enhance the retention of polar analytes.

Results:

Gradient separations were 10 minutes or less, depending on the amount of resolution required. Detection limits for the impurities/degradants were well below the 0.1% threshold.

Conclulsions:

Stability indicating-type separations for phenylephrine containing formulations were achieved using the new polar retention phase for UPLC.


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