Fluconazole related substance detection method

• Main Authors: HE WEIXUAN, ZENG PENGWEN, ZHANG JUAN, ZHAO TONGHUA, XIAO BIRONG
• Format: Patent
• Language: Chinese; English
• Published: 25.08.2020
• Subjects: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIRCHEMICAL OR PHYSICAL PROPERTIES; MEASURING; PHYSICS; TESTING

The invention discloses a fluconazole related substance detection method which adopts a high performance liquid chromatography method to carry out qualitative or/and quantitative detection on fluconazole related substances. The detection conditions of the liquid chromatography are as follows: a chromatographic column is a C18 chromatographic column; a mobile phase comprises a water phase and an organic phase; the water phase is a phosphate buffer solution; the organic phase is a phosphate buffer solution; the organic phase is selected from acetonitrile; and the mobile phase adopts a gradient elution method. The method provided by the invention can effectively detect main drugs and other related impurities in fluconazole bulk drugs, has specificity and stability indication capability, has high sensitivity, and can detect impurities which cannot be detected in a plurality of Chinese pharmacopoeia methods. 本发明公开了氟康唑有关物质检测方法，采用高效液相色谱的方法对氟康唑有关物质进行定性或/和定量检测，液相色谱的检测条件包括：色谱柱为C18色谱柱，流动相包括水相、有机相，其中，水相为磷酸盐缓冲液；有机相为有机相，有机