HPLC Analysis of Drug Fluconazole and Related Impurities on Coresep 100 Mixed-Mode Column

HPLC Analysis of Drug Fluconazole and Related Impurities on Coresep 100 Mixed-Mode Column chromatogram
Conditions of Experiment
Column:
Coresep 100
Separation Modes:
reversed-phase and cation-exchange
Column Dimenstions: 4.6 x 150 mm
Mobile Phase: 35% ACN with 0.1% H3PO4
Detection: UV 235 nm
Sample: 0.3 mg/ml
Injection: 3 uL
Flow rate: 1 mL/min
Analytes
1. Fluconazole
2. Related Impurities

Class of compounds: Aromatic acid, Aromatic base, Drug
Nature of compounds: Basic, Hydrophilic, Hydrophobic

Application description

Fluconazole is an antifungal drug. It is a highly selective inhibitor of fungal cytochrome P-450 sterol C-14 α-demethyllation. Fluconazole is a potent inhibitor of CYP2C9. Fluconazole interferes with fungal ergosterol synthesis and downregulates the metallothionein gene. Fluconazole is a first-generation triazole antifungal medication. It differs from earlier azole antifungals (such as ketoconazole) because its structure contains a triazole ring instead of an imidazole ring. Fluconazole and related impurities were analyzed by mixed-mode chromatography on Coresep 100 HPLC column. Fluconazole is hydrophobic and slightly basic in nature. It is retained on Coresep 100 column by combining strong reversed-phase and weak cation-exchange mechanisms. The amount of oACN in mobile phase affects retention of this compound the most. Buffer concentration, buffer pH, and buffer nature can be used for fine tuning for the separation of fluconazole and related impurities. Various mobile phases can be used with Coresep 100 column to accommodate different detection techniques (UV, MS, CAD, ELSD detection). Core-shell mixed-mode columns provide a great combination of unique selectivity, speed, and efficiency.

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