HPLC法测定佐米曲普坦的含量及有关物质

Methodology for determination of zolmitriptan content and its impurities by HPLC

目的:建立HPLE法测定佐米曲普坦的含量及纯度。方法:采用Zorbax SB-C18色谱柱,分别以甲醇:0.025mol／L磷酸二氢钾(16:84)和甲醇:0.025 mol／L磷酸二氢钾:三乙胺(25:75:0.5,pH=3.5)为流动相,流速为1mL／min,在检测波长为220nm处检测。结果:本品在0.01mg／mL^0.15mg／mL浓度范围内呈直线关系,本品中杂质的最小检测限为0.01％。对4批样品进行检测均未检出杂质,而粗品检出明显杂质。结论:本方法可用于含量测定和有关物质的检查。

Objective: To develop high pressure liquid chromatography (HPLC) in order to detect the content and purity of zolmitriptan. Methods: Using ODS - C18 column,methanol;0. 025 mol/L KH2PO4 (16: 84)and methanol:0.025 mol/L KH2PO4:triethylamine(25:75:0. 5, pH = 3. 5) as mg/mL mobile phase, at a flow rate of 1mL/min, wavelength of detector was 220nm. Results: There is a good linear relationship within the range of 0.01mg/mL - 0. 15mg/mL( r = 0. 9999) .It was found that the minimum detective limits of the impurities were 0.01%.Four batches of zolmitriptan synthesized by our institute were analyzed and no impurities were found, but obvious impurities were delected in crude product samples. Conclusion: The method established in our experiment can be used to detect the zolmitriptan drug content and the impurities.