HPLC法测定丁酰化-5-氨基水杨酸-果胶共轭物的载药量

目的:建立测定丁酰化-5-氨基水杨酸-果胶共轭物载药量的方法。方法:共轭物碱液经水解酸中和后采用高效液相色谱法测定,色谱柱为KromasilC18,流动相为水相(0·15%三乙胺和0·15%冰醋酸)-甲醇(95:5,V/V),检测波长为240nm。结果:5-氨基水杨酸检测浓度的线性范围为1～100μg·mL-1(r=0·9999);平均回收率为99·90%,日内及日间RSD≤2·25%;共轭物载药量为12·76%(n=3)。结论:本方法简单、快速、准确性高,可用于共轭物载药量的测定。

Determination of Drug Loading Rate of Butyl-5-Aminosalicylic Acid-Pectin conjugates by HPLC

OBJECTIVE： To establish an HPLC method for the determination of the drug loading rate of butyl - 5 - aminosalicylic acidpectin conjugate. METHODS： The conjugate was hydrolyzed with base solution and neutralized with acid before being determined by HPLC. Kromasil CI, column was used as chromatographic column with mobile phase consisted of water （containing 0.15% triethylamine and 0.15% acetic acid） -methanol （95 ： 5, V/V）. The detection wavelength was set at 240 nm. RESULTS： The calibration curve of 5- aminosalicylic acid was linear over the range of 1--100μg·mL^-1（r = 0.999 9） at an average recovery of 99.90%. Both intra- day and inter- day RSD were less than 2.25%. The drug loading rate of the conjugate was 12.76 % （n = 3） . CONCLUSION： The method is simple, rapid, accurate, and suitable for the determination of drug - loading rate of conjugate.