反相高效液相色谱法测定5-氨基水杨酸相关物质、原料含量及缓释片含量

RP-HPLC determination of 5-aminosalicylic acid、its related compounds and extended release tablets

目的：应用高效液相色谱法测定5-氨基水杨酸原料药及缓释片的含量。方法：反相高效液相色谱法,选择Kromasil C18柱,以甲醇-磷酸盐缓冲液(35∶65)为流动相,流速1 ml·min^(-1),检测波长254 nm。结果：浓度与峰高的回归方程为Y=395.36+17.308X,相关系数r=0.9994,线性范围83.71～837.12 μg·ml-1,精密度RSD≤1.34%,辅料对制剂的含量测定无干扰,平均回收率99.25%,RSD=0.65%。结论：测定方法简便、准确、灵敏度高。

OBJECTIVE：RP-HPLC was employed in the determination of the content of material and extended release tablets of 5-aminosalicylic acid (5-ASA) and its extended release tablets.METHODS：RP-HPLC analysis was carried out by using Kromasil C18 columm,with methanol-phosphate buffer(35∶65) as mobile phase.Flow rate 1ml·min-1,detection wavelength 254nm.RESULTS：The regression equation of concentration and peak height was Y =359.36+17.308 X ,with r =0.9994,linear range from 83.71 μg·ml-1to 873.1 μg·ml-1, RSD of accuracy≤1.34%,and the average RSD of recovery was 0.65%.Additives had no disturbing on the determination of the preparation.CONCLUSIONS：The determination method is simple,accurate,and reliable.