Development and Validation of HPLC Method for Analysis of Impurities of Fosfluconazole in Pharmaceutical Products

The contents of three related substances in fosfluconazole were determined by high performance liquid chromatography (HPLC). The limit of detection (LOD) of the impurity A (2-(2,4-difluorophenyl)-1,3-bis (1H-1,2,4-triazole-1-yl)-2-propan-2-ol), the impurity B (2-(2,4-Difluorophenyl) -1-(1H-1,2,4-triazol-1-yl) -3-(4H-1,2,4- triazol-4-yl) propan-2-yl dihydrogen phosphate) and the impurity C (2-(2-fluorophenyl) -1,3-bis (1H-1,2,4-triazole -1-yl)-2-propyl dihydrogen phosphate) were 3.0, 3.0 and 5.0 μg/mL respectively. Limit of quantification (LOQ) were 10.0, 22.0 and 21.3 μg/mL for A, B and C. The method can be used for the quality control of the related substances in fluconazole injection, tablet and capsule.