Fluconazole Tablet Analyzed with HPLC - AppNote
June 17, 2013
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Date: 17-JUNE-2013 Last Updated: 20-AUGUST-2026
Assay Method for Amine Containing APIThis Application Note shows a simple Gradient Method for Assay of Fluconazole Tablets. In Reversed Phase HPLC, notable tailing was observed due to the two heterocyclic amine groups. Use of HILIC HPLC produced a sharp Peak for this API. Data from three different Column lots is shown in order to demonstrate the Method Reproducibility and Robustness.
Peak:
Fluconazole
Method Conditions
Column: Cogent Diamond Hydride™, 4 μm, 100 Å
Catalog No.: 70000-7.5P
Dimensions: 4.6 x 75 mm
Mobile Phase:
--
A: DI Water with 0.1% Formic Acid (v/v)
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B: Acetonitrile with 0.1% Formic Acid (v/v)
Gradient:
| Time (minutes) | %B |
|---|---|
| 0 | 95 |
| 1 | 95 |
| 6 | 40 |
| 7 | 40 |
Post Time: 3 minutes
Injection vol.: 1 μL
Flow rate: 1.0 mL / minute
Detection: UV @ 260 nm
Sample Preparation: 150 mg strength Fluconazole Tablet was ground and added to 50 mL volumetric flask containing 25 mL 50:50 Solvent A / Solvent B diluent. The solution was sonicated 10 minutes, diluted to mark, and mixed. A portion was filtered through a 0.45 μm Nylon Syringe Filter (MICROSOLV).
t 0 : 0.9 minutes
Note: Fluconazole is a triazole antifungal drug. Its mode of action is inhibition of fungal Cytochrome P450 enzyme 14a-demethylase. It is available under the trade name Diflucan®.
