Ibuprofen Assay Method Reproducibility with HPLC – AppNote

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ARTICLES, APPNOTES, FAQ (9289)
- AppNotes Library (1888)
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- Frequently Asked Questions?? (3402)
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July 19, 2012
Bill Ciccone

AppNotes Cogent Bidentate C18 / AppNotes Library / AppNotes Pharmaceuticals / AppNotes Reversed Phase Methods / ARTICLES, APPNOTES, FAQ

Extremely Precise, Assay Method

This Assay Method for a common Ibuprofen formulation demonstrates Reproducibility and Robustness as the Figure below shows an overlay of four Chromatograms with different Columns lots (%RSD < 1).

An important aspect of Column Selection for a Method is that the Retention behavior is consistent across numerous manufacturing batches. This is especially crucial once a Method has been validated and is in routine use.

Peak:
Ibuprofen

Method Conditions
Column: Cogent Bidentate C18™, (BDC18), 4μm, 100Å
Catalog No.: 40018-75P
Dimensions: 4.6 x 75mm
Mobile Phase:
—A: DI Water with 0.1% Formic Acid
—B: Acetonitrile with 0.1% Formic Acid
Gradient:

Time (minutes)	%B
0	30
2	30
6	70
7	30

Post Time: 3 minutes
Injection vol.: 10μL
Flow rate: 1.0mL / minute
Detection: UV @ 254nm
Sample Preparation: 200mg strength Advil® tablet was ground and added to a 50mL volumetric flask with a diluent of 1:1 Solvent A / Solvent B. It was sonicated 10 minutes and diluted to mark. Then a portion was filtered with a 0.45μm Nylon Syringe Filter (MicroSolv Tech Corp.).
t0: 0.9 minutes

Note: Ibuprofen is a nonsteroidal anti inflammatory drug (NSAID) commonly used for its analgesic effects. It is marketed under a variety of trade names such as Advil and Motrin®. In addition, it is often included in combination formulations as well.

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