Development and Validation of HPLC Method for Analysis of Impurities of Fosfluconazole in Pharmaceutical Products
Journal Title: Journal of Pharmaceutical Research International - Year 2016, Vol 13, Issue 1
Abstract
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.
Authors and Affiliations
Qiang Li, Juan Liu, Jie Chen, Yi Huang, Xiaohong Yuan, Liangchun Li
Keywords
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- EP ID EP342070
- DOI 10.9734/BJPR/2016/28451
- Views 62
- Downloads 0
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