Fluconazole Tablet Analyzed with HPLC - AppNote
June 17, 2013
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Assay Method for Amine Containing API
This 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 Aqueous Normal Phase (ANP) 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.
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 Tech Corp.).
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®.
This 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 Aqueous Normal Phase (ANP) 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)
--
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 Tech Corp.).
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®.