Polar API Separated from a Matrix Peak

Oxymetazoline can be difficult to obtain a good Peak Shape with conventional HPLC Methods, and the USP System Suitability requires that the Tailing Factor be not more than 2.0. Also, the USP Method calls for a Cation Exchange (L9) Column for the Assay. This Method produces excellent Peak Shape also shows Separation of the API from a matrix component or another ingredient in the formulation.

Two runs from different Column batches are overlaid in the Chromatogram to show the Method Robustness and Precision.


Peaks:
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2. Matrix component

Method Conditions
Column: Cogent Diamond Hydride™, 4μm, 100Å
Catalog No.: 70000-7.5P
Dimensions: 4.6 x 75mm
Mobile Phase:
A: DI Water with 0.1% Trifluoroacetic Acid (TFA)
B: Acetonitrile with 0.1% Trifluoroacetic Acid (TFA)
Gradient:

Time (minutes) %B
0 97
1 97
6 40
7 97

Post Time: 3 minutes
Injection vol.: 1μL
Flow rate: 1.0mL / minute
Detection: UV @ 280nm
Sample Preparation: Nasal spray solution containing 0.05% Oxymetazoline HCL was filtered with a 0.45μm Nylon Syringe Filter (MicroSolv Tech Corp.) and used for injections.
t0: 0.9 minutes

Note: Oxymetazoline is a decongestant that acts as a selective alpha-1 agonist and partial alpha-2 agonist. It is the active ingredient in many nasal spray solutions. It also has vasoconstriction properties and is therefore used in eye drop solutions as well.

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