HPLC法测定枸橼酸托法替布片的含量

Content Determination of Active Ingredients in Tofacitinib Citrate Tablets by HPLC

建立一种液相色谱分析方法,测定枸橼酸托法替布片的含量。采用色谱柱ZORBAX SB-C18 (15 cm×4.6 mm,3μm);乙腈-磷酸盐缓冲液(20︰80)为流动相;检测波长为286 nm;流速为1.0 m L/min;柱温为30℃;采集时间为20 min;进样体积为20μL。结果显示托法替布线性范围为19.965~199.653μg·mL^(-1)(r=0.999);枸橼酸托法替布平均回收率为100.5%,RSD为0.6%。该方法简单准确、重复性好,可用于枸橼酸托法替布片的含量测定。

The high-performance liquid chromatography(HPLC) method was established to determine the content of tofacitinib citrate tablets. Tofacitinib citrate was determined by HPLC as follows: chromatographic column, ZORBAX SB-C18(15 cm×4.6 mm, 3 μm);mobile phase, acetonitrile-phosphate buffer(20︰80);detection wavelength, 286 nm;flow rate, 1.0 mL/min;column temperature, 30 ℃;acquisition time, 20 min;injection volume, 20 μL. The liner range of tofacitinib was 19.965~199.653 μg·mL^(-1)(r=0.999). The average recovery rate of tofacitinib(n=9) was 100.5 % with its RSD value of 0.6 %. The method was simple,accurate and repeatable, which was suitable for the content determination of active ingredients in tofacitinib citrate tablets.