Ephedrine, Guaifenes in Primatene Tablet Analyzed with HPLC - AppNote
May 29, 2013
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Separation of Guaifenesin and Ephedrine from an OTC Formulation
These two compounds are used together in the Primatene® formulation for the purpose of treating Bronchial Asthma. The Separation obtained illustrates the application of this Method in the Analysis of an Over the Counter Formulation.
A wavelength change was used in order to make the two peak heights more comparable (there is much more Guaifenesin than Ephedrine in the tablet). Data from two different Column lots is shown in the figure in order to demonstrate the reproducibility of this Method.
Column: Cogent Bidentate C18™, 4 μm, 100Å
Catalog No.: 40018-75P
Dimensions: 4.6 x 75 mm
Mobile Phase:
-- A: DI Water with 0.1% TFA (v/v)
-- B: Acetonitrile with 0.1% TFA (v/v)
Gradient:
Post Time: 3 mi nutes (3.3 Column Volumes)
Injection vol.: 2μL
Flow rate: 1.0 mL / minute
Detection: UV @ 214 nm (0-4.5 minutes) , then 285 nm (4.5-10 minutes)
Sample Preparation:
Attachment No 252 Primatene Tablet Analyzed with HPLC pdf 0.3 Mb Download File
These two compounds are used together in the Primatene® formulation for the purpose of treating Bronchial Asthma. The Separation obtained illustrates the application of this Method in the Analysis of an Over the Counter Formulation.
A wavelength change was used in order to make the two peak heights more comparable (there is much more Guaifenesin than Ephedrine in the tablet). Data from two different Column lots is shown in the figure in order to demonstrate the reproducibility of this Method.
Peaks:
1. Ephedrine,
2. Guaifenesin
Column: Cogent Bidentate C18™, 4 μm, 100Å
Catalog No.: 40018-75P
Dimensions: 4.6 x 75 mm
Mobile Phase:
-- A: DI Water with 0.1% TFA (v/v)
-- B: Acetonitrile with 0.1% TFA (v/v)
Gradient:
| Time (minutes) | %B |
|---|---|
| 0 | 5 |
| 1 | 5 |
| 6 | 50 |
| 7 | 5 |
Post Time: 3 mi nutes (3.3 Column Volumes)
Injection vol.: 2μL
Flow rate: 1.0 mL / minute
Detection: UV @ 214 nm (0-4.5 minutes) , then 285 nm (4.5-10 minutes)
Sample Preparation:
- The stock solution was prepared by dissolving 1.0 mg of standards in 10.00 mL of the Mobile Phase (50:50 Solvent A / Solvent B) . The solution was then filtered with a 0.45 μm Nylon Syringe Filter (MICROSOLV Tech Corp.). The injection sample was diluted 1:10.
- A Primatene® Tablet containing 12.5 mg Ephedrine HCL and 200 mg Guaifenesin was ground and added to a 25 mL volumetric flask. A portion of 50:50 Solvent A / Solvent B diluent was added and the flask was sonicated 10 minutes. It was then diluted to mark and mixed. A portion was filtered with a 0.45 μm Nylon Syringe Filter (MICROSOLV Tech Corp.) and diluted 1:10.
Attachment No 252 Primatene Tablet Analyzed with HPLC pdf 0.3 Mb Download File