HPLC法测定替吉奥片中3种成分的含量

Determination of Three Components in Tegafur,Gimeracil and Oteracil Potassium Tablets by HPLC

建立高效液相色谱法测定替吉奥片中奥替拉西钾、吉美拉西以及替加氟的含量。采用KromasilC18色谱柱;流动相:磷酸二氢钾缓冲溶液(取磷酸二氢钾1.36g,加水800mL与三乙胺10mL,用磷酸调pH至4.5)-甲醇(85∶15),流速:1.0mL·min-1,检测波长:266nm,进样量:10μL,柱温:室温。奥替拉西钾、吉美拉西和替加氟分别在0.17～2.82μg(r=0.9993),0.06～0.81μg(r=0.9996),0.16～2.88μg(r=0.9998)范围内线性良好。平均回收率分别为99.8%(RSD=0.31%),99.7%(RSD=0.73%),99.9%(RSD=0.38%)。该方法简单、灵敏、准确、专属性强,可用于替吉奥片的质量控制。

A HPLC method for the quantitative analysis of three contents in Tegafur, Gimeracil and Oteracil Potassium Tablets was established. The column was Kromasil C18 column. The mobile phase was potassium dihydrogen phosphate buffer solution （dissolve 1.36g potassium dihydrogen phosphate in 800mL of water and 10mL of triethylamine, adjust to pH 4.5 by H3PO4） -methanol （85 ： 15）. The detection wavelength was 266nm. The column temperature was kept at the room temperature. The flowrate was 1.0mL · min^-1. The calibration curves of oteracil potassium, gimeracil, and tegafur were linear in the range of 0.17 0 2. 82μg, 0. 06 - 0. 81μg, 0.16 - 2. 88μg, respectively. The average recovery was 99.8%, 99.7%, 99.9%, and RSD was 0. 31%, 0.73%, 0.38% （n=5）, respectively. The method is simple, sensitive and accurate. It can be used for determination of Tegafur, Gimeracil and Oteracil Potassium Tablets.