高效液相色谱法测定茚地那韦胶囊含量及有关物质

Assay and test for related substance of Indinavir capsules by HPLC

目的:建立一种高效液相色谱法测定茚地那韦胶囊含量及有关物质的方法。方法:色谱柱为 C_8柱;流动相为0.02mol·L^(-1)枸橼酸钠缓冲液(用稀盐酸调 pH 至4.0)-乙腈(45:55);检测波长为260nm;流速为1.0mL·min^(-1)。结果:茚地那韦在0.153～0.612mg·mL^(-1)的范围内,峰面积与浓度呈线性关系,r=0.9999(n=7),平均回收率为100.01%,RSD 为0.68%。结论:用 HPLC 法测定茚地那韦胶囊含量及有关物质方法简便,结果准确。

Objective：A HPLC methods was established for the determination of Indinavir capsules and its related substances. Method ：The column ： shim - pack Alhima Cs column （ 250 mm × 4. 6 mm 5 μm）. The mobile phase ： 0. 02 mol · L 6- 1 citrate buffer - acetonitrile （45 ： 55 ）. The detective wavelength ： 260 nm. The flow rate ： 1.0 mL · min^-1. Result：standard curve was linear in the range of 0. 153 -0. 612 mg · mL^-1 and thecorrelation coefficient was 0. 9999. The average recovery was100. 01% （RSD = 0. 68%, n = 9）. Conclusion：The method is easy to operate and the results of the determination is accurate.