European Pharmacopeia Monograph 2287 Fluconazole: Efficient Separation on Fully Porous and Core-Shell C18 Columns Within the Allowable Adjustments

Abstract:

Fluconazole [2-(2,4-Difluorophenyl)-1,3-bis(1H-1,2,4-triazol-1-yl) propan-2-ol] is a triazole based systemic antifungal medication. It belongs to the first-generation antifungals used for oral treatment of Candida infections. The desirable pharmacologic properties of Fluconazole include a relatively long half-life, and the ability to be administered orally or parentally. The monograph for related substances of Fluconazole specifies three main impurities (A [2(RS)-2-(2,4-Difluorophenyl)-1-(1H-1,2,4-triazol-1-yl)-3- (4H-1,2,4-triazol-4yl)propan-2-ol], B {2-[2-fluoro-4-(1H-1,2,4-triazol- 1-yl)phenyl]-1,3-bis(1H-1,2,4-triazol-1yl)propan-2-ol}, and C [1,1’-(1,3-phenylene)di-1H-1,2,4-triazole]) which need to be separated and detected to demonstrate compliance.

Document Type:

Technical Notes

Industries:

Pharmaceutical/Biopharmaceutical

Techniques:

HPLC / UHPLC

Brands:

Kinetex Luna

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