Development and Validation of HPLC Method for Analysis of Impurities of Fosfluconazole in Pharmaceutical Products
Qiang Li
School of Life Science and Engineering, Southwest University of Science and Technology, Mianyang 621010, China.
Juan Liu
School of Life Science and Engineering, Southwest University of Science and Technology, Mianyang 621010, China.
Jie Chen
School of Life Science and Engineering, Southwest University of Science and Technology, Mianyang 621010, China.
Yi Huang
School of Life Science and Engineering, Southwest University of Science and Technology, Mianyang 621010, China.
Xiaohong Yuan
School of Life Science and Engineering, Southwest University of Science and Technology, Mianyang 621010, China.
Liangchun Li *
School of Life Science and Engineering, Southwest University of Science and Technology, Mianyang 621010, China.
*Author to whom correspondence should be addressed.
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.
Keywords: Fosfluconazole, fluconazol, impurity, HPLC