Determination of Diisopropyl Sulfate in Ezetimibe by GC / 中国药师

ABSTRACT

Objective:To establish a method for the determination of diisopropyl sulfate in ezetimibe. Methods:Diisopropyl sul-fate was determined by GC with a DB-FFAP capillary column (30 m × 0. 32 mm, 0. 5 μm) and an FID. The carrier gas was nitrogen and the flow rate was 2. 0 ml·min-1 . The temperature program was as follows: the initial column temperature was 40 ℃, and then raised to 180 ℃ at a rate of 25℃·min-1 ,and maintained for 2 min. Results:Diisopropyl sulfate had a good linear relationship with-in the range of 4. 040-13. 466 μg·ml-1(r=0. 999 8). The average recovery was 97. 57%and RSD was 2. 37% (n=9). Conclu-sion:The method is specific and reproducible with high sensitivity, which can be used to determine the content of diisopropyl sulfate in ezetimibe.