高效液相色谱法测定全反式维甲酸软胶囊的含量

Determination of all-trans-retinoic acid(ATRA) soft gelatin capsule by HPLC

目的 :建立全反式维甲酸 (ATRA)软胶囊含量的测定方法。方法 :采用高效液相色谱法 ,色谱柱 μBondapakC18(10μm ,3.9mm× 30 0mm) ,流动相为甲醇 醋酸铵缓冲液 (85∶15 ) ,流速 0 .8ml·min-1,紫外检测波长 34 0nm ,柱温 2 2℃ ,检测灵敏度 0 .0 0 2AUFS。结果 :ATRA在 41.0 4～ 2 87.2 8μg·ml-1范围内线性关系良好 ,回归方程为 Y =- 95 85 0 6 .49X +110 375 .98,r=0 .9994(n =7) ,平均回收率为 98.5 8% ,RSD =1.5 6 % (n =5 )。结论 :本方法测定ATRA软胶囊含量 ,方法准确。

OBJECTIVE To establish a method for the determination of the content of all trans retinoic acid (ATRA) soft gelatin capsule. METHODS An HPLC method was utilized, ATRA was seperated on a μBondapak C 18 column(10 μm, 3.9 mm×300 mm) and detected at 340 nm,using methanol NH 4Ac buffer(85∶15) as the mobile phase, the flow rate was 0.8 ml·min -1 ,the column temperature was kept at 22 ℃.RESULTS The calibration curve was linear within the range from 41.04 to 287.28 μg·ml -1 ,Y= -958506.49X + 110375.98 ,r= 0.9994 (n=7),the average recovery was 98.58% , RSD= 1.56% (n=5) .CONCLUSIONS This method is accurate and reproducible.